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MEASUREMENT SYSTEMS ANALYSIS Reference Manual Fourth Edition

First Edition, October 1990 • Second Edition, February 1995; Second Printing, June 1998 Third Edition, March 2002; Second Printing, May 2003; Fourth Edition, June 2010 Copyright © 1990, © 1995, © 2002, © 2010 Chrysler Group LLC, Ford Motor Company, General Motors Corporation ISBN#: 978-1-60-534211-5

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FOREWORD This Reference Manual was developed by a Measurement Systems Analysis (MSA) Work Group, sanctioned by the Chrysler Group LLC, Ford Motor Company, and General Motors Corporation Supplier Quality Requirements Task Force, and under the auspices of the Automotive Industry Action Group (AIAG). The Work Group responsible for this Fourth Edition were Michael Down (General Motors Corporation), Frederick Czubak (Chrysler Group LLC), Gregory Gruska (Omnex), Steve Stahley (Cummins, Inc.) and David Benham. The manual is an introduction to measurement system analysis. It is not intended to limit evolution of analysis methods suited to particular processes or commodities. While these guidelines are intended to cover normally occurring measurement system situations, there will be questions that arise. These questions should be directed to your authorized customer representative. This Manual is copyrighted by Chrysler Group LLC, Ford Motor Company, and General Motors Corporation, with all rights reserved, 2010. Additional manuals can be ordered from AIAG at www.aiag.org. Permission to reproduce portions of this manual for use within supplier organizations may be obtained from AIAG at www.aiag.org U

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June 2010

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MSA 4th Edition Quick Guide Type of Measurement System

MSA Methods

Chapter

Basic Variable

Range, Average & Range, ANOVA, Bias, Linearity, Control Charts

III

Basic Attribute

Signal Detection, Hypothesis Test Analyses

III

Non-Replicable (e.g., Destructive Tests)

Alternate Approaches

IV

Complex Variable

Range, Average & Range, ANOVA, Bias Linearity Control Charts

III, IV

Multiple Systems, Gages or Test Stands

Control Charts ANOVA Regression Analysis

III, IV

Miscellaneous

Alternate Approaches

IV

Other

White Papers – available at AIAG website (www.aiag.org)

NOTE: Regarding the use of the GRR standard deviation Historically, by convention, a 99% spread has been used to represent the “full” spread of measurement error, represented by a 5.15 multiplying factor (where V GRR is multiplied by 5.15 to represent a total spread of 99%).

A 99.73% spread is represented by a multiplier of 6.0, which is r3V and represents the full spread of a “normal” curve. If the reader chooses to increase the coverage level, or spread, of the total measurement variation to 99.73%, use 6.0 as a multiplier in place of 5.15 in the calculations. Note: The approach used in the 4th Edition is to compare standard deviations. This is equivalent to using the multiplier of 6 in the historical approach. Awareness of which multiplying factor is used is crucial to the integrity of the equations and resultant calculations. This is especially important if a comparison is to be made between measurement system variability and the tolerance. Consequently, if an approach other than that described in this manual is used, a statement of such must be stated clearly in any results or summaries (particularly those provided to the customer).

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TABLE OF CONTENTS MSA 4th Edition Quick Guide .....................................................................................................................................iv TABLE OF CONTENTS ............................................................................................................................................v List of Tables............................................................................................................................................................. vii List of Figures .......................................................................................................................................................... viii CHAPTER I General Measurement System Guidelines.........................................................................................1 Section A Introduction, Purpose and Terminology ...................................................................................................3 Introduction ...........................................................................................................................................................3 Purpose ..................................................................................................................................................................4 Terminology ..........................................................................................................................................................4 Section B The Measurement Process P.....................................................................................................................13 Measurement Systems .........................................................................................................................................13 The Effects of Measurement System Variability.................................................................................................18 Section C Measurement Strategy and Planning.......................................................................................................25 Section D Measurement Source Development .......................................................................................................29 Gage Source Selection Process............................................................................................................................31 Section E Measurement Issues ................................................................................................................................41 Section F Measurement Uncertainty........................................................................................................................63 Section G Measurement Problem Analysis .............................................................................................................65 CHAPTER II General Concepts for Assessing Measurement Systems ...............................................................67 Section A Background.............................................................................................................................................69 Section B Selecting/Developing Test Procedures....................................................................................................71 Section C Preparation for a Measurement System Study ........................................................................................73 Section D Analysis of the Results............................................................................................................................77 CHAPTER III Recommended Practices for Replicable Measurement Systems ................................................81 Section A Example Test Procedures........................................................................................................................83 Section B Variable Measurement System Study Guidelines ...................................................................................85 Guidelines for Determining Stability...................................................................................................................85 Guidelines for Determining Bias PF – Independent Sample Method ...................................................................87 Guidelines for Determining Bias – Control Chart Method..................................................................................92 Guidelines for Determining Linearity P................................................................................................................96 Guidelines for Determining Repeatability and Reproducibility P ......................................................................101 Range Method....................................................................................................................................................102 Average and Range Method ..............................................................................................................................103 Analysis of Variance (ANOVA) Method ..........................................................................................................123 Section C Attribute Measurement Systems Study .................................................................................................131 Risk Analysis Methods ......................................................................................................................................131 Signal Detection Approach................................................................................................................................143 Analytic Method P ..............................................................................................................................................145 CHAPTER IV Other Measurement Concepts and Practices .............................................................................151 Section A Practices for Non-Replicable Measurement Systems ...........................................................................153 Destructive measurement systems .....................................................................................................................153 Systems where the part changes on use/test ......................................................................................................153 Section B Stability Studies ....................................................................................................................................155 Section C Variability Studies.................................................................................................................................161 Section D Recognizing the Effect of Excessive Within-Part Variation................................................................167 Section E Average and Range Method – Additional Treatment............................................................................169 Section F Gage Performance Curve P.....................................................................................................................177 Section G Reducing Variation Through Multiple Readings ..................................................................................183 Section H Pooled Standard Deviation Approach to GRR P ....................................................................................185 APPENDICES..........................................................................................................................................................193

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Appendix A...............................................................................................................................................................195 Analysis of Variance Concepts..............................................................................................................................195 Appendix B...............................................................................................................................................................199 Impact of GRR on the Capability Index Cp ...........................................................................................................199 Formulas:...............................................................................................................................................................199 Analysis: ................................................................................................................................................................199 Graphical Analysis ................................................................................................................................................201 Appendix C...............................................................................................................................................................203 Appendix D...............................................................................................................................................................205 Gage R Study.........................................................................................................................................................205 Appendix E...............................................................................................................................................................207 Alternate PV Calculation Using Error Correction Term........................................................................................207 Appendix F ...............................................................................................................................................................209 P.I.S.M.O.E.A. Error Model..................................................................................................................................209 Glossary ....................................................................................................................................................................213 Reference List ..........................................................................................................................................................219 Sample Forms ..........................................................................................................................................................223 Index .........................................................................................................................................................................227

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List of Tables Table I-B1: Control Philosophy and Driving Interest.................................................................................. 18 Table II-D 1: GRR Criteria........................................................................................................................... 78 Table III-B 1: Bias Study Data.................................................................................................................... 90 Table III-B 2: Bias Study – Analysis of Bias Study P .................................................................................. 92 Table III-B 3: Bias Study – Analysis of Stability Study for Bias.................................................................. 95 Table III-B 4: Linearity Study Data ............................................................................................................. 99 Table III-B 5: Linearity Study – Intermediate Results ................................................................................ 99 Table III-B 6: Gage Study (Range Method) ............................................................................................. 103 Table III-B 6a: Gage Repeatability and Reproducibility Data Collection Sheet .......................................105 Table III-B 7: ANOVA Table ..................................................................................................................... 127 Table III-B 8: ANOVA Analysis % Variation & Contribution ...................................................................... 127 Table III-B 9: Comparison of ANOVA and Average and Range Methods ............................................... 129 Table III-B 10: GRR ANOVA Method Report .......................................................................................... 129 Table III-C 1: Attribute Study Data Set...................................................................................................... 134 Table III-C 2: Cross tabulation Study Results ........................................................................................... 136 Table III-C 3: Kappa Summary ................................................................................................................. 137 Table III-C 4: Comparisons of Appraisers to Reference ........................................................................... 138 Table III-C 5: Study Effectiveness Table................................................................................................... 139 Table III-C 6: Example Effectiveness Criteria Guidelines ......................................................................... 140 Table III-C 7: Study Effectiveness Summary ............................................................................................ 140 Table III-C 8: Table III-C 1 sorted by Ref Value........................................................................................ 143 Table IV-A 1: Methods Based on Type of Measurement System............................................................ 154 Table IV-H 1: Pooled Standard Deviation Analysis Data Set ................................................................... 189 Table A 1: Estimate of Variance Components ......................................................................................... 195 Table A 2: 6 Sigma Spread ...................................................................................................................... 196 Table A 3: Analysis of Variance (ANOVA) ............................................................................................... 197 Table A 4: Tabulated ANOVA Results ..................................................................................................... 198 Table A 5: Tabulated ANOVA Results ..................................................................................................... 198 Table B 1: Comparison of Observed to Actual Cp...................................................................................201 Table C 1:

d 2* Table .............................................................................................................................. 203

Table F 1: Examples of the PISMOEA Model.......................................................................................... 211

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List of Figures Figure I-A 1: Example of a Traceability Chain for a Length Measurement ................................................ 10 Figure I-B 1: Measurement System Variability Cause and Effect Diagram ................................................ 17 Figure I-E 2: Discrimination ........................................................................................................................46 Figure I-E 3: Impact of Number of Distinct Categories (ndc) of the Process Distribution on Control and Analysis Activities ................................................................................................................................ 47 Figure I-E 4: Process Control Charts ......................................................................................................... 49 Figure I-E 5: Characteristics of the Measurement Process Variation ......................................................... 50 Figure I-E 6: Relationships between Bias and Repeatability ..................................................................... 62 Figure III-B 1: Control Chart Analysis for Stability ..................................................................................... 86 Figure III-B 2: Bias Study – Histogram of Bias Study ................................................................................ 91 Figure III-B 3: Linearity Study – Graphical Analysis ................................................................................100 Figure III-B 4: Average Chart – “Stacked”................................................................................................107 Figure III-B 5: Average Chart – “Unstacked”............................................................................................107 Figure III-B 6: Range Chart – “Stacked” ..................................................................................................108 Figure III-B 7: Range Chart – “Unstacked” ..............................................................................................109 Figure III-B 8: Run Chart by Part .............................................................................................................109 Figure III-B 9: Scatter Plot ........................................................................................................................110 Figure III-B 10: Whiskers Chart ................................................................................................................111 Figure III-B 11: Error Charts .....................................................................................................................112 Figure III-B 12: Normalized Histogram .....................................................................................................113 Figure III-B 13: X–Y Plot of Averages by Size .........................................................................................114 Figure III-B 14: Comparison X–Y Plots ....................................................................................................115 Figure III-B 15: Completed GR&R Data Collection Sheet ....................................................................... 118 Figure III-B 16: Gage Repeatability and Reproducibility Report .............................................................. 119 Figure III-B 18: Residual Plot ...................................................................................................................126 Figure III-C 1: Example Process with Pp = Ppk = 0.50.............................................................................132 Figure III-C 2: The “Gray” Areas Associated with the Measurement System ........................................... 132 Figure III-C 3: Example Process with Pp = Ppk = 1.33.............................................................................141 Figure III-C 4: Attribute Gage Performance Curve Plotted on Normal Probability Paper ........................ 149 Figure III-C 5. Attribute Gage Performance Curve ..................................................................................150 U

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Figure IV-E 1: Measurement Evaluation Control Chart ( X U

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& R ) - 1 ...................................................... 172 U

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Figure IV-E 2: Measurement Evaluation Control Chart ( X & R ) - 2 ...................................................... 173 Figure IV-E 3: Alternate Computations for Evaluating a Measurement Process (Part 1 of 2)................. 174 Figure IV-E 4: Alternate Computations for Evaluating a Measurement Process (Part 2 of 2)................. 175 Figure IV-F 1: Gage Performance Curve Without Error ...........................................................................180 Figure IV-F 2: Gage Performance Curve –Example ................................................................................181 Figure IV-F 3: Gage Performance Curve Plotted on Normal Probability Paper ...................................... 182 Figure IV-H 1: Pooled Standard Deviation Study Graphical Analysis ..................................................... 188 Figure IV-H 2: Dot diagram of h values....................................................................................................191 Figure IV-H 3: Dot diagram of k values. ...................................................................................................192 Figure B 1: Observed vs. Actual Cp (process based) ..............................................................................201 Figure B 2: Observed vs. Actual Cp (tolerance based) ...........................................................................202 U

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viii

Chapter I General Measurement System Guidelines

CHAPTER I General Measurement System Guidelines

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Chapter I – Section A Introduction, Purpose and Terminology

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Chapter I – Section A Introduction, Purpose and Terminology

Section A Introduction, Purpose and Terminology Introduction Measurement data are used more often and in more ways than ever before. For instance, the decision to adjust a manufacturing process is now commonly based on measurement data. The data, or some statistic calculated from them, are compared with statistical control limits for the process, and if the comparison indicates that the process is out of statistical control, then an adjustment of some kind is made. Otherwise, the process is allowed to run without adjustment. Another use of measurement data is to determine if a significant relationship exists between two or more variables. For example, it may be suspected that a critical dimension on a molded plastic part is related to the temperature of the feed material. That possible relationship could be studied by using a statistical procedure called regression analysis to compare measurements of the critical dimension with measurements of the temperature of the feed material. Studies that explore such relationships are examples of what Dr. W. E. Deming called analytic studies. In general, an analytic study is one that increases knowledge about the system of causes that affect the process. Analytic studies are among the most important uses of measurement data because they lead ultimately to better understanding of processes. The benefit of using a data-based procedure is largely determined by the quality of the measurement data used. If the data quality is low, the benefit of the procedure is likely to be low. Similarly, if the quality of the data is high, the benefit is likely to be high also. To ensure that the benefit derived from using measurement data is great enough to warrant the cost of obtaining it, attention needs to be focused on the quality of the data.

Quality of Measurement Data

The quality of measurement data is defined by the statistical properties of multiple measurements obtained from a measurement system operating under stable conditions. For instance, suppose that a measurement system, operating under stable conditions, is used to obtain several measurements of a certain characteristic. If the measurements are all “close” to the master value for the characteristic, then the quality of the data is said to be “high”. Similarly, if some, or all, of the measurements are “far away” from the master value, then the quality of the data is said to be “low”. The statistical properties most commonly used to characterize the quality of data are the bias and variance of the measurement system. The property called bias refers to the location of the data relative to a reference (master) value, and the property called variance refers to the spread of the data. One of the most common reasons for low-quality data is too much variation. Much of the variation in a set of measurements may be due to the interaction between the measurement system and its environment. For instance, a

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Chapter I – Section A Introduction, Purpose and Terminology

measurement system used to measure the volume of liquid in a tank may be sensitive to the ambient temperature of the environment in which it is used. In that case, variation in the data may be due either to changes in the volume or to changes in the ambient temperature. That makes interpreting the data more difficult and the measurement system, therefore, less desirable. If the interaction generates too much variation, then the quality of the data may be so low that the data are not useful. For example, a measurement system with a large amount of variation may not be appropriate for use in analyzing a manufacturing process because the measurement system’s variation may mask the variation in the manufacturing process. Much of the work of managing a measurement system is directed at monitoring and controlling variation. Among other things, this means that emphasis needs to be placed on learning how the measurement system interacts with its environment so that only data of acceptable quality are generated.

Purpose The purpose of this document is to present guidelines for assessing the quality of a measurement system. Although the guidelines are general enough to be used for any measurement system, they are intended primarily for the measurement systems used in the industrial world. This document is not intended to be a compendium of analyses for all measurement systems. Its primary focus is measurement systems where the readings can be replicated on each part. Many of the analyses are useful with other types of measurement systems and the manual does contain references and suggestions. It is recommended that competent statistical resources be consulted for more complex or unusual situations not discussed here. Customer approval is required for measurement systems analysis methods not covered in this manual.

Terminology The discussion of the analysis of measurement system can become confusing and misleading without an established set of terms to refer to the common statistical properties and related elements of the measurement system. This section provides a summary of such terms which are used in this manual. In this document, the following terms are used: x

Measurement is defined as “the assignment of numbers [or values] to material things to represent the relations among them with respect to particular properties.” This definition was first given by C. Eisenhart (1963). The process of assigning the numbers is defined as the measurement process, and the value assigned is defined as the measurement value.

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Chapter I – Section A Introduction, Purpose and Terminology

x x

Gage is any device used to obtain measurements; frequently used to refer specifically to the devices used on the shop floor; includes go/no-go devices (also, see Reference List: ASTM E456-96). Measurement System is the collection of instruments or gages, standards, operations, methods, fixtures, software, personnel, environment and assumptions used to quantify a unit of measure or fix assessment to the feature characteristic being measured; the complete process used to obtain measurements.

From these definitions it follows that a measurement process may be viewed as a manufacturing process that produces numbers (data) for its output. Viewing a measurement system this way is useful because it allows us to bring to bear all the concepts, philosophy, and tools that have already demonstrated their usefulness in the area of statistical process control.

Summary of Terms 1 P

Standard x x x x

Accepted basis for comparison Criteria for acceptance Known value, within stated limits of uncertainty, accepted as a true value Reference value A standard should be an operational definition: a definition which will yield the same results when applied by the supplier or customer, with the same meaning yesterday, today, and tomorrow.

Basic equipment x

x

1

Discrimination, readability, resolution

9 Alias: smallest readable unit, measurement resolution, scale limit, or detection limit 9 An inherent property fixed by design 9 Smallest scale unit of measure or output for an instrument 9 Always reported as a unit of measure 9 10 to 1 rule of thumb Effective resolution

9 The sensitivity of a measurement system to process variation for a particular application

See Chapter I, Section E for terminology definitions and discussion.

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Chapter I – Section A Introduction, Purpose and Terminology

9 Smallest input that results in a usable output signal of measurement 9 Always reported as a unit of measure x

Reference value

x

True value

9 Accepted value of an artifact 9 Requires an operational definition 9 Used as the surrogate for the true value 9 Actual value of an artifact 9 Unknown and unknowable

Location variation x

x

Accuracy

9 “Closeness” to the true value, or to an accepted reference value 9 ASTM includes the effect of location and width errors Bias

9 Difference between the observed average of measurements and the reference value 9 A systematic error component of the measurement system

x

Stability

x

Linearity

9 The change in bias over time 9 A stable measurement process is in statistical control with respect to location 9 Alias: Drift

9 The change in bias over the normal operating range 9 The correlation of multiple and independent bias errors over the operating range 9 A systematic error component of the measurement system

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Chapter I – Section A Introduction, Purpose and Terminology

Width variation x

Precision 2

x

Repeatability

C

GRR

2

9 Variation in measurements obtained with one measuring instrument when used several times by an appraiser while measuring the identical characteristic on the same part 9 The variation in successive (short-term) trials under fixed and defined conditions of measurement 9 Commonly referred to as E.V. – Equipment Variation 9 Instrument (gage) capability or potential 9 Within-system variation

x

Reproducibility

x

GRR or Gage R&R

x

Measurement System Capability

Reference Value

A

9 “Closeness” of repeated readings to each other 9 A random error component of the measurement system P

B

9 Variation in the average of the measurements made by different appraisers using the same gage when measuring a characteristic on one part 9 For product and process qualification, error may be appraiser, environment (time), or method 9 Commonly referred to as A.V. – Appraiser Variation 9 Between-system (conditions) variation 9 ASTM E456-96 includes repeatability, laboratory, and environmental effects as well as appraiser effects

9 Gage repeatability and reproducibility: the combined estimate of measurement system repeatability and reproducibility 9 Measurement system capability; depending on the method used, may or may not include the effects of time

9 Short-term estimate of measurement system variation (e.g., “GRR” including graphics)

In ASTM documents, there is no such thing as the precision of a measurement system; i.e., the precision cannot be represented by a single number.

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Chapter I – Section A Introduction, Purpose and Terminology

x

Measurement System Performance

x

Sensitivity

9 Long-term estimate of measurement system variation (e.g., longterm Control Chart Method)

9 Smallest input that results in a detectable output signal 9 Responsiveness of the measurement system to changes in measured feature 9 Determined by gage design (discrimination), inherent quality (Original Equipment Manufacturer), in-service maintenance, and operating condition of the instrument and standard 9 Always reported as a unit of measure

x

Consistency

x

Uniformity

9 The degree of change of repeatability over time 9 A consistent measurement process is in statistical control with respect to width (variability)

9 The change in repeatability over the normal operating range 9 Homogeneity of repeatability

System variation Measurement system variation can be characterized as:

The measurement system must be stable and consistent.

x

Capability

x

Performance

x

Uncertainty

9 Variability in readings taken over a short period of time

9 Variability in readings taken over a long period of time 9 Based on total variation 9 An estimated range of values about the measured value in which the true value is believed to be contained

All characterizations of the total variation of the measurement system assume that the system is stable and consistent. For example, the components of variation can include any combination of the items shown in I-B 1.

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Chapter I – Section A Introduction, Purpose and Terminology

Standards and Traceability

National Measurement Institutes

Traceability

The National Institute of Standards and Technology (NIST) is the principal National Measurements Institute (NMI) in the United States serving under the U.S. Department of Commerce. NIST, formerly the National Bureau of Standards (NBS), serves as the highest level authority for metrology in the U.S. NIST’s primary responsibility is to provide measurement services and maintain measurement standards that assist U.S. industry in making traceable measurements which ultimately assist in trade of products and services. NIST provides these services directly to many types of industries, but primarily to those industries that require the highest level of accuracy for their products and that incorporate state-of-the-art measurements in their processes. Most of the industrialized countries throughout the world maintain their own NMIs and similar to NIST, they also provide a high level of metrology standards or measurement services for their respective countries. NIST works collaboratively with these other NMIs to assure measurements made in one country do not differ from those made in another. This is accomplished through Mutual Recognition Arrangements (MRAs) and by performing interlaboratory comparisons between the NMIs. One thing to note is that the capabilities of these NMIs will vary from country to country and not all types of measurements are compared on a regular basis, so differences can exist. This is why it is important to understand to whom measurements are traceable and how traceable they are. Traceability is an important concept in the trade of goods and services. Measurements that are traceable to the same or similar standards will agree more closely than those that are not traceable. This helps reduce the need for re-test, rejection of good product, and acceptance of bad product. Traceability is defined by the ISO International Vocabulary of Basic and General Terms in Metrology (VIM) as: “The property of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties.” The traceability of a measurement will typically be established through a chain of comparisons back to the NMI. However, in many instances in industry, the traceability of a measurement may be linked back to an agreed upon reference value or “consensus standard” between a customer and a supplier. The traceability linkage of these consensus standards to the NMI may not always be clearly understood, so ultimately it is critical that the measurements are traceable to the extent that satisfies customer needs. With the advancement in measurement technologies and the usage of state-of-theart measurement systems in industry, the definition as to where and how a measurement is traceable is an ever-evolving concept.

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Chapter I – Section A Introduction, Purpose and Terminology

Wavelength Standard

Interference Comparator

Reference Standard

Laser Interferometer

Reference Gage Blocks/Comparator

Working Standard

CMM

Gage Blocks

Production Gage

Fixture Gage

Micrometers

National Standard

Figure I-A 1: Example of a Traceability Chain for a Length Measurement NMIs work closely with various national labs, gage suppliers, state-of-the-art manufacturing companies, etc. to assure that their reference standards are properly calibrated and directly traceable to the standards maintained by the NMI. These government and private industry organizations will then use their standards to provide calibration and measurement services to their customers’ metrology or gage laboratories, calibrating working or other primary standards. This linkage or chain of events ultimately finds its way onto the factory floor and then provides the basis for measurement traceability. Measurements that can be connected back to NIST through this unbroken chain of measurements are said to be traceable to NIST. Not all organizations have metrology or gage laboratories within their facilities therefore depend on outside commercial/independent laboratories to provide traceability calibration and measurement services. This is an acceptable and appropriate means of attaining traceability to NIST, provided that the capability of the commercial/independent laboratory can be assured through processes such as laboratory accreditation.

Calibration Systems

A calibration system is a set of operations that establish, under specified conditions, the relationship between a measuring device and a traceable standard of known reference value and uncertainty. Calibration may also include steps to detect, correlate, report, or eliminate by adjustment any discrepancy in accuracy of the measuring device being compared. The calibration system determines measurement traceability to the measurement systems through the use of calibration methods and standards. Traceability is the chain of calibration events originating with the calibration standards of appropriate metrological capability or measurement uncertainty. Each calibration event includes all of the elements necessary including standards, measurement and test equipment being verified, calibration methods and procedures, records, and qualified personnel.

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Chapter I – Section A Introduction, Purpose and Terminology

An organization may have an internal calibration laboratory or organization which controls and maintains the elements of the calibration events. These internal laboratories will maintain a laboratory scope which lists the specific calibrations they are capable of performing as well as the equipment and methods/procedures used to perform the calibrations. The calibration system is part of an organization’s quality management system and therefore should be included in any internal audit requirements. Measurement Assurance Programs (MAPs) can be used to verify the acceptability of the measurement processes used throughout the calibration system. Generally MAPs will include verification of a measurement system’s results through a secondary independent measurement of the same feature or parameter. Independent measurements imply that the traceability of the secondary measurement process is derived from a separate chain of calibration events from those used for the initial measurement. MAPs may also include the use of statistical process control (SPC) to track the long-term stability of a measurement process. Note: ANSI/NCSL Z540.3 and ISO 10012 each provide models for many of the elements of a calibration system.

When the calibration event is performed by an external, commercial, or independent calibration service supplier, the service supplier’s calibration system can (or may) be verified through accreditation to ISO/IEC 17025. When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer.

True Value

The measurement process TARGET is the “true” value of the part. It is desired that any individual reading be as close to this value as (economically) possible. Unfortunately, the true value can never be known with certainty. However, uncertainty can be minimized by using a reference value based on a well defined operational definition of the characteristic, and using the results of a measurement system that has higher order discrimination and traceable to NIST. Because the reference value is used as a surrogate for the true value, these terms are commonly used interchangeably. This usage is not recommended.

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Chapter I – Section A Introduction, Purpose and Terminology

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Chapter I – Section B The Measurement Process

Section B The Measurement Process3 P

Measurement Systems In order to effectively manage variation of any process, there needs to be knowledge of: x x x

What the process should be doing What can go wrong What the process is doing

Specifications and engineering requirements define what the process should be doing. The purpose of a Process Failure Mode Effects Analysis 4 (PFMEA) is to define the risk associated with potential process failures and to propose corrective action before these failures can occur. The outcome of the PFMEA is transferred to the control plan. P

F

Knowledge is gained of what the process is doing by evaluating the parameters or results of the process. This activity, often called inspection, is the act of examining process parameters, in-process parts, assembled subsystems, or complete end products with the aid of suitable standards and measuring devices which enable the observer to confirm or deny the premise that the process is operating in a stable manner with acceptable variation to a customer designated target. But this examination activity is itself a process.

General Process Input

Operation

Output

Measurement Process

Unfortunately, industry has traditionally viewed the measurement and analysis activity as a “black box”. Equipment was the major focus – the more "important" the characteristic, the more expensive the gage. The 3

4

Portions of this chapter adapted with permission from Measurement Systems Analysis - A Tutorial by G. F. Gruska and M. S. Heaphy, The Third Generation, 1987, 1998. See the Potential Failure Mode and Effects Analysis (FMEA) Reference Manual – 4th Edition.

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Chapter I – Section B The Measurement Process

usefulness of the instrument, its compatibility with the process and environment, and its usability was rarely questioned. Consequently these gages were often not used properly or simply not used. The measurement and analysis activity is a process – a measurement process. Any and all of the management, statistical, and logical techniques of process control can be applied to it. This means that the customers and their needs must first be identified. The customer, the owner of the process, wants to make a correct decision with minimum effort. Management must provide the resources to purchase equipment which is necessary and sufficient to do this. But purchasing the best or the latest measurement technology will not necessarily guarantee correct production process control decisions. Equipment is only one part of the measurement process. The owner of the process must know how to correctly use this equipment and how to analyze and interpret the results. Management must therefore also provide clear operational definitions and standards as well as training and support. The owner of the process has, in turn, the obligation to monitor and control the measurement process to assure stable and correct results which includes a total measurement systems analysis perspective – the study of the gage, procedure, user, and environment; i.e., normal operating conditions.

Statistical Properties of Measurement Systems

An ideal measurement system would produce only “correct” measurements each time it is used. Each measurement would always agree with a standard. 5 A measurement system that could produce measurements like that would be said to have the statistical properties of zero variance, zero bias, and zero probability of misclassifying any product it measured. Unfortunately, measurement systems with such desirable statistical properties seldom exist, and so process managers are typically forced to use measurement systems that have less desirable statistical properties. The quality of a measurement system is usually determined solely by the statistical properties of the data it produces over time. Other properties, such as cost, ease of use, etc., are also important in that they contribute to the overall desirability of a measurement system. But it is the statistical properties of the data produced that determine the quality of the measurement system. P

F

Statistical properties that are most important for one use are not necessarily the most important properties for another use. For instance, for some uses of a coordinate measuring machine (CMM), the most important statistical properties are “small” bias and variance. A CMM with those properties will generate measurements that are “close” to the certified values of standards that are traceable. Data obtained from such a machine can be very useful for analyzing a manufacturing process. But, no matter how “small” the bias and variance of the CMM may be, the measurement system which uses the CMM may be unable to do an acceptable job of discriminating between good and bad product because of the additional sources of variation introduced by the other elements of the measurement system. 5

For a fuller discussion on the matter of standards see Out of the Crisis, W. Edwards Deming, 1982, 1986, p. 279-281.

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Chapter I – Section B The Measurement Process

Management has the responsibility for identifying the statistical properties that are the most important for the ultimate use of the data. Management is also responsible for ensuring that those properties are used as the basis for selecting a measurement system. To accomplish this, operational definitions of the statistical properties, as well as acceptable methods of measuring them, are required. Although each measurement system may be required to have different statistical properties, there are certain fundamental properties that define a “good” measurement system. These include: 1) Adequate discrimination and sensitivity. The increments of measure should be small relative to the process variation or specification limits for the purpose of measurement. The commonly known Rule of Tens, or 10-to-1 Rule, states that instrument discrimination should divide the tolerance (or process variation) into ten parts or more. This rule of thumb was intended as a practical minimum starting point for gage selection. 2) The measurement system ought to be in statistical control.FP6PF This means that under repeatable conditions, the variation in the measurement system is due to common causes only and not due to special causes. This can be referred to as statistical stability and is best evaluated by graphical methods. 3) For product control, variability of the measurement system must be small compared to the specification limits. Assess the measurement system to the feature tolerance. 4) For process control, the variability of the measurement system ought to demonstrate effective resolution and be small compared to manufacturing process variation. Assess the measurement system to the 6-sigma process variation and/or Total Variation from the MSA study.

The statistical properties of the measurement system may change as the items being measured vary. If so, then the largest (worst) variation of the measurement system is small relative to the smaller of either the process variation or the specification limits.

Sources of Variation

Similar to all processes, the measurement system is impacted by both random and systematic sources of variation. These sources of variation are due to common and special causes. In order to control the measurement system variation: 1) Identify the potential sources of variation. 2) Eliminate (whenever possible) or monitor these sources of variation. Although the specific causes will depend on the situation, some typical sources of variation can be identified. There are various methods of

6

The measurement analyst must always consider practical and statistical significance.

15

Chapter I – Section B The Measurement Process

presenting and categorizing these sources of variation such as cause-effect diagrams, fault tree diagrams, etc., but the guidelines presented here will focus on the major elements of a measuring system. S W I P E

Standard Workpiece (i.e., part) Instrument Person / Procedure Environment

The acronym S.W.I.P.E. 7 is used to represent the six essential elements of a generalized measuring system to assure attainment of required objectives. S.W.I.P.E. stands for Standard, Workpiece, Instrument, Person and Procedure, and Environment. This may be thought of as an error model for a complete measurement system. 8 P

F

P

Factors affecting those six areas need to be understood so they can be controlled or eliminated. Figure I-B 1 displays a cause and effect diagram showing some of the potential sources of variation. Since the actual sources of variation affecting a specific measurement system will be unique to that system, this figure is presented as a thought starter for developing a measurement system’s sources of variation.

7

This acronym was originally developed by Ms. Mary Hoskins, a metrologist associated with Honeywell, Eli Whitney Metrology Lab and the Bendix Corporation. 8 See Appendix F for an alternate error model, P.I.S.M.O.E.A. T

T

16

Workpiece (Part)

17

cleanliness

elastic properties supporting features

build variation

interrelated characteristics

build

adequate datums

stability

hidden geometry

calibration

operational definition

build tolerances

use assumptions

design

contact geometry

bias

deformation effects

stability

consistency

design validation - clamping - locators - measurement points - measurement probes

maintenance coef of thermal expansion

amplification

robustness

linearity

sensitivity uniformity

repeatability variability

traceability calibration p.m.

elastic properties

Standard

reproducibility

Measurement System Variability

educational experience

geometric compatibility

physical training

air drafts thermal expansion

sun people artificial

lights

air pollution vibration

components

operational definition visual standards

equalization -system components cycles

temperature

limitations

standard vs ambient

lighting stress

Environment

experience

procedures

ergonomics

skill

attitude Person (Appraiser)

training

understanding

Chapter I – Section B The Measurement Process

Figure I-B 1: Measurement System Variability Cause and Effect Diagram

mass

elastic deformation

Instrument (Gage)

Chapter I – Section B The Measurement Process

The Effects of Measurement System Variability Because the measurement system can be affected by various sources of variation, repeated readings on the same part do not yield the same, identical result. Readings vary from each other due to common and special causes. The effects of the various sources of variation on the measurement system should be evaluated over a short and long period of time. The measurement system capability is the measurement system (random) error over a short period of time. It is the combination of errors quantified by linearity, uniformity, repeatability and reproducibility. The measurement system performance, as with process performance, is the effect of all sources of variation over time. This is accomplished by determining whether our process is in statistical control (i.e., stable and consistent; variation is due only to common causes), on target (no bias), and has acceptable variation (gage repeatability and reproducibility (GRR)) over the range of expected results. This adds stability and consistency to the measurement system capability. Because the output of the measurement system is used in making a decision about the product and the process, the cumulative effect of all the sources of variation is often called measurement system error, or sometimes just “error.”

Effect on Decisions

After measuring a part, one of the actions that can be taken is to determine the status of that part. Historically, it would be determined if the part were acceptable (within specification) or unacceptable (outside specification). Another common scenario is the classification of parts into specific categories (e.g., piston sizes). For the rest of the discussion, as an example, the two category situation will be used: out of specification (“bad”) and in specification (“good”). This does not restrict the application of the discussion to other categorization activities.

Further classifications may be reworkable, salvageable or scrap. Under a product control philosophy this classification activity would be the primary reason for measuring a part. But, with a process control philosophy, interest is focused on whether the part variation is due to common causes or special causes in the process. Philosophy

Interest

Product control

Is the part in a specific category?

Process control

Is the process variation stable and acceptable?

Table I-B1: Control Philosophy and Driving Interest

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Chapter I – Section B The Measurement Process

The next section deals with the effect of the measurement error on the product decision. Following that is a section which addresses its impact on the process decision.

Effect on Product Decisions

In order to better understand the effect of measurement system error on product decisions, consider the case where all of the variability in multiple readings of a single part is due to the gage repeatability and reproducibility. That is, the measurement process is in statistical control and has zero bias. A wrong decision will sometimes be made whenever any part of the above measurement distribution overlaps a specification limit. For example, a good part will sometimes be called “bad” (type I error, producer's risk or false alarm) if:

And, a bad part will sometimes be called “good” (type II error, consumer’s risk or miss rate) if:

NOTE: False Alarm Rate + Miss Rate = Error Rate. RISK is the chance of making a decision which will be detrimental to an individual or process That is, with respect to the specification limits, the potential to make the wrong decision about the part exists only when the measurement system error intersects the specification limits. This gives three distinct areas:

19

Chapter I – Section B The Measurement Process

where: I

Bad parts will always be called bad

II

Potential wrong decision can be made

III

Good parts will always be called good

Since the goal is to maximize CORRECT decisions regarding product status, there are two choices: 1) Improve the production process: reduce the variability of the process so that no parts will be produced in the II or “shaded” areas of the graphic above. 2) Improve the measurement system: reduce the measurement system error to reduce the size of the II areas so that all parts being produced will fall within area III and thus minimize the risk of making a wrong decision. This discussion assumes that the measurement process is in statistical control and on target. If either of these assumptions is violated then there is little confidence that any observed value would lead to a correct decision.

Effect on Process Decisions

With process control, the following needs to be established: x x x

Statistical control On target Acceptable variability

As explained in the previous section, the measurement error can cause incorrect decisions about the product. The impact on process decisions would be as follows: x x

Calling a common cause a special cause Calling a special cause a common cause

Measurement system variability can affect the decision regarding the stability, target and variation of a process. The basic relationship between the actual and the observed process variation is:

20

Chapter I – Section B The Measurement Process 2 V obs

where

2 2 V actual  V msa

2 V obs

= observed process variance

2 V msa

= variance of the measurement system

2 V actual = actual process variance

The capability index 9 Cp is defined as P

Cp

F

ToleranceRange 6V

The relationship between the Cp index of the observed process and the Cp indices of the actual process and the measurement system is derived by substituting the equation for Cp into the observed variance equation above:

 Cp obs  Cp actual 2

2

  Cp msa 2

Assuming the measurement system is in statistical control and on target, the actual process Cp can be compared graphically to the observed Cp. 10 P

F

Therefore the observed process capability is a combination of the actual process capability plus the variation due to the measurement process. To reach a specific process capability goal would require factoring in the measurement variation. For example, if the measurement system Cp index were 2, the actual process would require a Cp index greater than or equal to 1.79 in order for the calculated (observed) index to be 1.33. If the measurement system Cp index were itself 1.33, the process would require no variation at all if the final result were to be 1.33 – clearly an impossible situation.

9 10

Although this discussion is using Cp, the results hold also for the performance index Pp. See Appendix B for formulas and graphs.

21

Chapter I – Section B The Measurement Process

New Process Acceptance

When a new process such as machining, manufacturing, stamping, material handling, heat treating, or assembly is purchased, there often is a series of steps that are completed as part of the buy-off activity. Oftentimes this involves some studies done on the equipment at the supplier's location and then at the customer's location. If the measurement system used at either location is not consistent with the measurement system that will be used under normal circumstances then confusion may ensue. The most common situation involving the use of different instruments is the case where the instrument used at the supplier has higher order discrimination than the production instrument (gage). For example, parts measured with a coordinate measuring machine during buyoff and then with a height gage during production; samples measured (weighed) on an electronic scale or laboratory mechanical scale during buyoff and then on a simple mechanical scale during production. In the case where the (higher order) measurement system used during buy-off has a GRR of 10% and the actual process Cp is 2.0 the observed process Cp during buy-off will be 1.96. 11 P

F

Runoff part variation CMM variation

When this process is studied in production with the production gage, more variation (i.e., a smaller Cp) will be observed. For example, if the GRR of the production gage is 30% and the actual process Cp is still 2.0 then the observed process Cp will be 1.71. A worst case scenario would be if a production gage has not been qualified but is used. If the measurement system GRR is actually 60% (but that fact is not known), then the observed Cp would be 1.28. The difference in the observed Cp of 1.96 versus 1.28 is due to the different measurement system. Without this knowledge, efforts may be spent, in vain, looking to see what went wrong with the new process.

11

For this discussion, assume there is no sampling variation. In reality 1.96 will be the expected value but actual results will vary around it.

22

Chapter I – Section B The Measurement Process

Actual process variation Production gage variation

Observed process variation

Process Setup/ Control (Funnel Experiment)

Often manufacturing operations use a single part at the beginning of the day to verify that the process is targeted. If the part measured is off target, the process is then adjusted. Later, in some cases another part is measured and again the process may be adjusted. Dr. Deming referred to this type of measurement and decision-making as tampering. Consider a situation where the weight of a precious metal coating on a part is being controlled to a target of 5.00 grams. Suppose that the results from the scale used to determine the weight vary r0.20 grams but this is not known since the measurement system analysis was never done. The operating instructions require the operator to verify the weight at setup and every hour based on one sample. If the results are beyond the interval 4.90 to 5.10 grams then the operator is to setup the process again. At setup, suppose the process is operating at 4.95 grams but due to measurement error the operator observes 4.85 grams. According to instructions the operator attempts to adjust the process up by .15 grams. Now the process is running at 5.10 grams for a target. When the operator checks the setup this time, 5.08 grams is observed so the process is allowed to run. Over-adjustment of the process has added variation and will continue to do so. This is one example of the funnel experiment that Dr. Deming used to describe the effects of tampering. 12 The measurement error just compounds the problem. P

F

Four rules of the funnel experiment are: Rule 1: Make no adjustment or take no action unless the process is unstable. Rule 2: Adjust the process in an equal amount and in an opposite direction from where the process was last measured to be. Rule 3: Reset the process to the target. Then adjust the process in an equal amount and in an opposite direction from the target. Rule 4: Adjust the process to the point of the last measurement. The setup instruction for the precious metal process is an example of Rule 3. Rules 2, 3 and 4 add progressively more variation. Rule 1 is the best choice to produce minimum variation. 12

Deming, W. Edwards, Out of the Crisis, Massachusetts Institute of Technology, 1982, 1986.

23

Chapter I – Section B The Measurement Process

Other examples of the funnel experiment are: x

x x x x

Recalibration of gages based on arbitrary limits – i.e., limits not reflecting the measurement system’s variability. (Rule 3) (Re)mastering the process control measurement system after an arbitrary number of uses without any indication or history of a change (special cause). (Rule 3) Autocompensation adjusts the process based on the last part produced. (Rule 2) On the job training (OJT) where worker A trains worker B who later trains worker C... without standard training material. Similar to the “post office” game. (Rule 4) Parts are measured, found to be off target, but when plotted on a control chart the process is shown to be stable – therefore, no action is taken. (Rule 1)

24

Chapter I – Section C Measurement Strategy and Planning

Section C Measurement Strategy and Planning Planning is key before designing and purchase of measurement equipment or systems. Many decisions made during the planning stage could affect the direction and selection of measurement equipment. What is the purpose and how will the measurement result be used? The planning stage will set the course and have a significant effect on how well the measurement process operates and can reduce possible problems and measurement error in the future.

In some cases due to the risk involved in the component being measured or because of the cost and complexity of the measurement device, the OEM customer may use the APQP process and committee to decide on the measurement strategy at the supplier.

Not all product and process characteristics require measurement systems whose development falls under this type of scrutiny. Simple standard measurement tools like micrometers or calipers may not require this in-depth strategy and planning. A basic rule of thumb is whether the characteristic being measured on the component or sub-system has been identified in the control plan or is important in determining the acceptance of the product or process. Another guide would be the level of tolerance assigned to a specific dimension. Common sense is the guide in any case.

Complexity

The type, complexity, and purpose of a measurement system may drive various levels of program management, strategic planning, measurement systems analysis, or other special consideration for measurement selection, assessment and control. Simple measuring tools and devices (i.e., scales, measuring tapes, fixed-limit or attribute gages) may not require the level of management, planning, or analysis that more complex or critical measuring systems demand (i.e., master or reference, CMM, test stand, automated online gaging, etc.). Any measurement system may require more or less strategic planning and scrutiny depending on a given product or process situation. The decision as to the appropriate level shall be left to the APQP team assigned to the measurement process and customer. The actual degree of involvement or implementation in many of the activities below should be driven by the particular measurement system, consideration of the supporting gage control and calibration system, profound process knowledge, and common sense.

25

Chapter I – Section C Measurement Strategy and Planning

Identify the Purpose of the Measurement Process Measurement Life Cycle

The first step is to establish the purpose for the measurement and how the measurement will be utilized. A cross-functional team organized early in the development of the measurement process is critical in accomplishing this task. Specific considerations are made in relation to audit, process control, product and process development and analysis of the “Measurement Life Cycle”. The Measurement Life Cycle concept expresses the belief that the measurement methods may change over time as one learns and improves the process. For example, measurement may start on a product characteristic to establish stability and capability of the process. This may lead to an understanding of critical process control characteristics that directly affect the part characteristics. Dependency on part characteristic information becomes less and the sampling plan may be reduced to signify this understanding (five parts per hour sample reduced to one part per shift). Also, the method of measurement may change from a CMM measurement, to some form of attribute gaging. Eventually it may be found that very little part monitoring may be required as long as the process is maintained or measuring and monitoring the maintenance and tooling may be all that is needed. The level of measurement follows the level of process understanding. Most of the measuring and monitoring could eventually end up at suppliers of incoming material. The same measurement, on the same characteristic, at the same area of the process, over an extensive period of time is evidence of a lack of learning or a stagnant measurement process.

Criteria for a Measurement Process Design Selection

Before a measurement system can be purchased, a detailed engineering concept of the measurement process is developed. Using the purpose developed above, a cross-functional team of individuals will develop a plan and concept for the measurement system required by the design. Here are some guidelines: The team needs to evaluate the design of the subsystem or component and identify important characteristics. These are based on customer requirements and the functionality of the subsystem or component to the total system. If the important dimensions have been identified already, evaluate the ability to measure the characteristics. For example, if the important characteristic of a plastic injection molded component was on the mold parting line, the dimensional check would be difficult and measurement variation would be high. One method to capture issues similar to these would be to use a FMEA process to analyze areas of risk in gage design both from an ability to measure to the part to the functionality gage (Design and Process FMEA). This would aid in the development of the maintenance and calibration plan. Develop a flow chart showing critical process steps in the manufacturing or assembly of the part or subsystem. Identify key inputs and outputs to each step in the process. This will aid in the development of the measurement equipment criteria and requirements affected by the location in the process.

26

Chapter I – Section C Measurement Strategy and Planning

A measurement plan, a list of measurement types, comes out of this investigation. 13 P

For complex measurement systems, a flow chart is made of the measurement process. This would include delivery of the part or sub-system being measured, the measurement itself, and the return of the part or sub-system to the process. Next use some method of brainstorming with the group to develop general criteria for each measurement required. One of the simple methods to use is a cause and effect diagram. 14 See the example in Figure I-B 1 as a thought starter. P

F

A few additional questions to consider in relation to measurement planning: x x

x x x x x

Who ought to be involved in the “needs” analysis? The flow chart and initial discussion will facilitate the identification of the key individuals. Why will measurement be taken and how will it be used? Will the data be used for control, sorting, qualification, etc? The way the measurement will be used can change the sensitivity level of the measurement system. What level of sensitivity will be required? What is the product specification? What is the expected process variability? How much of a difference between parts will the gage need to detect? What type of information will be provided with the gage (e.g., manuals – operating, maintenance, etc.) and what basic operator skills are required? Who will do the training? How are measurements taken? Will it be done manually, on a moving conveyor, off-line, automatically, etc? Are the part location and fixturing possible sources of variation? Contact or non-contact? How will the measurement be calibrated and will it be compared with other measurement processes? Who will be responsible for the calibration masters? When and where will the measurement be taken? Will the part be clean, oily, hot, etc.? Remember to use data to substantiate common assumptions about the measurement process. It is better to be safe and collect data on the environment, rather than to make decisions based on the wrong information and having a system developed that is not robust to environmental issues.

13 14

This can be considered as a preliminary control plan. See Guide to Quality Control, Kaoru Ishikawa, published by Asian Productivity Organization, 1986.

27

Chapter I – Section C Measurement Strategy and Planning

Research Various Measurement Process Methods

Develop and Design Concepts and Proposals

Current measurement methods should be researched prior to investing in new equipment. Proven measurement methods may provide more reliable operation. Where possible, use measurement equipment that has a proven track record.

Refer to “Suggested Elements for a Measurement System Development Checklist” at the end of Chapter I, Section D, when developing and designing concepts and proposals. During and after the fabrication of the measurement equipment and development of the measurement process (methods, training, documentation, etc.), experimental studies and data collection activities will be performed. These studies and data will be used to understand this measurement process so that this process and future processes may be improved.

28

Chapter I – Section D Measurement Source Development

Section D Measurement Source Development

MEASUREMENT PROCESS

This section addresses the quotation/procurement timeframe of the life of a measurement process. It has been constructed to be a self-contained discussion about the process of developing a measurement process quotation package, obtaining responses to that package, awarding the project, completing final design, developing the measurement process, and, finally, marrying that measurement process to the production process for which it was created. It is strongly encouraged that this chapter not be used without reading and understanding the entire discussion about a measurement process. To obtain the most benefit from the measurement process, study and address it as a process with inputs and outputs. 15 P

INPUT

OUTPUT

This chapter was written with the team philosophy in mind. It is not a job description for the buyer or purchasing agent. The activities described here will require team involvement to be completed successfully and it should be administered within the overall framework of an Advanced Product Quality Planning (APQP) team. This can result in healthy interplay between various team functions – concepts arising out of the planning process may be modified before the gage supplier arrives at a final design that satisfies the measurement system requirements. Generally, the “acquisition process” begins with formal communication between the customer and supplier for a given project. Up-front communication is crucial to the success of the project, since the groundwork necessary for an effective future customer/supplier relationship will be done at this stage. The acquisition process begins with the customer’s formal presentation of the intent of the project in the form of a Request For Quote (RFQ) followed by the supplier’s formal explanation of their proposal to meet this intent (the Quotation). The customer and supplier(s) need to thoroughly understand the project requirements, what the deliverables will be and the methods by which both are to be achieved. This understanding is derived from accurate timely communication between the two parties. Once a concept has been agreed upon and a customer/supplier relationship has been established for the project at hand, the detailed design, fabrication of the measurement process, and development activities can commence. Communication between the customer and the supplier at this time is especially important. Since there may be several levels of concept approvals to be carried out, and possible environmental changes and the potential of team members changing, the measurement process project could falter or even fail. This risk will be reduced if frequent, detailed communication is maintained and documented between the customer and supplier and formal responsibility (an individual) for maintaining communication is designated 15

See Chapter I, Section B

29

Chapter I – Section D Measurement Source Development

by both parties. The ideal forum and format for this activity is the Advanced Product Quality Planning (APQP) process. After the measurement process has been conceptually designed, the activities surrounding the acquisition of the process/system can begin.

Datum Coordination

Ideally, with the current prevalence in the use of Geometric Dimensioning & Tolerancing (GD&T), datums need to be coordinated (i.e., made identical) throughout the manufacturing process and the measurement system and this needs to be established very early in the APQP process. Initial responsibility for this may lie with the product design engineer, dimensional control, etc. depending on the specific organization. When datum schemes do not match throughout a manufacturing process, particularly in the measurement systems, this leads to a situation where the wrong things may be measured, and there may be fit problems, etc., leading to ineffective control of the manufacturing process. There may be times when a datum scheme used in a final assembly cannot possibly match that used in a sub-component manufacturing process. When such is the case, it can be established as early as possible in the APQP process so that all team members understand possible difficulties and conflicts that may lie ahead and have every opportunity to do something about it. During this process, different datum schemes may need to be explored in order to understand the impact of these differences. Certain commodities present features which can yield more problems than others, such as camshaft centering, or other round, cylindrical or tubular characteristics. For example, a camshaft must be manufactured on centers but the important product features are in its lobes. One method or datum scheme may be required for manufacturing whereas another scheme is required for measurement of the final product measurement.

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Chapter I – Section D Measurement Source Development

Prerequisites and Assumptions

Before discussing the development of a gage supplier, it will be assumed that issues such as “correct” engineering product design (GD&T) and “correct” process design (one which allows for measurement at the proper time and location in the process) have been resolved. However this should not detract from consideration of these issues with appropriate team members early in the APQP process. It is assumed that the gage supplier will be involved with the APQP process, a team approach. The gage supplier will develop a clear appreciation of the overall production process and product usage so that his role is understood not only by him but by others on the team (manufacturing, quality, engineering, etc.). There may be slight overlap in some activities or the order of those activities depending on the particular program/project or other constraints. For instance, the APQP team without much input from a gage source may develop certain gage concepts. Other concepts may require the expertise of the gage source. This may be driven by the complexity of the measurement system and a team decision as to what makes sense.

Gage Source Selection Process Develop the Quotation Package

Detailed Engineering Concept

Before a measurement process request for quotation package can be supplied to a potential supplier for formal proposals, a detailed engineering concept of the measurement process needs to be developed. The team of individuals that will employ and be responsible for the maintenance and continual improvement of the measurement process have direct responsibility for developing the detailed concept. This can be part of the APQP team. To better develop this concept, several questions need to be answered. The team may research various issues to help decide which direction or path will be followed for designing the measurement process. Some may be dictated or heavily implied by the product design. Examples of the multitude of possible issues that need to be addressed by the team when developing this detailed concept may be found in the “Suggested Elements for a Measurement System Development Checklist” at the end of this section.

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Chapter I – Section D Measurement Source Development

All too often, customers rely too heavily on suppliers for solutions. Before a customer asks a supplier to suggest solutions to process problems, the foundation and intent of the process needs to be thoroughly understood and anticipated by the team that owns that process. Then and only then will the process be properly used, supported and improved upon.

Preventive Maintenance Considerations

What activities should be scheduled for preventive maintenance (e.g., lubrication, vibration analysis, probe integrity, parts replacement, etc.)? Much of these activities will depend on the complexity of the measurement system, device or apparatus. Simpler gages may require only an inspection at regular intervals, whereas more complex systems may require ongoing detailed statistical analyses and a team of engineers to maintain in a predictive fashion. Planning preventive maintenance activities should coincide with the initiation of the measurement process planning. Many activities, such as draining air filters daily, lubricating bearings after the designated number of operating hours, etc., can be planned before the measurement system is completely built, developed and implemented. In fact this is preferable and improves advanced measurement planning and costs. Data collection methods and maintenance recommendations related to these activities can be obtained from the original manufacturer, or developed by plant engineering, manufacturing and quality personnel. After the measurement process is implemented and in use, data pertaining to the function of the measurement process need to be collected and plotted over time. Simple analytical methods (run charts, trend analysis) can be conducted to determine the stability of the system. Eventually, as the judgment of system stability dictates, preventive maintenance routines can be scheduled accordingly. Conducting preventive maintenance on a stable system, based on time series information, will be less wasteful than conducting preventive maintenance on a system with traditional techniques.

Specifications

Specifications serve as guidelines for both the customer and supplier in the design and build process. These guidelines serve to communicate acceptable standards. Acceptable standards may be considered in two categories: x x

Design Standards Build Standards

Format of the design standards may be different depending on who is paying for the project. Cost issues may affect the format. Generally, it is a good idea to have sufficient documented design detail that the design may be built or repaired to original intent by any qualified builder – however, this decision

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Chapter I – Section D Measurement Source Development

may be driven by cost and criticality. The required format of the final design may be some form of computer assisted design (CAD) or hardcopy engineering drawings. It may involve engineering standards chosen from those of the OEM, SAE, ASTM, or other organization, and the gage supplier must have access to the latest level and understand these standards. The OEM may require the use of particular standards at either the design or build phase and may even require formal approvals before the measurement system may be released for use. Design standards will detail the method of communicating the design (CAD – e.g., CATIA, Unigraphics, IGES, manual hardcopy, etc.) to the builder. It may also cover performance standards for a more complex measurement system. Build standards will cover the tolerances to which the measurement system must be built. Build tolerance should be based on a combination of the capabilities of the process used to produce the gage or gage component, and the criticality of the intended measurement. Build tolerance should not be a mere given percent of product tolerance alone. If duplicate fixtures or systems are required, proper planning and standardizing can lead to interchangeability and flexibility.

Use of standard(ized) components or subassemblies also leads to interchangeability, flexibility, reduced cost and, generally, less long-term measurement error. As quotations are received, the team ought to assemble to review and evaluate them. Certain items can be noted:

Evaluate the Quotations

C O N C E P T

Q U O T E

APPROVAL

9 Are the basic requirements met? 9 Are there any outstanding concerns? 9 Do any of the suppliers exhibit an exceptional condition and why? (An exceptional condition could be a significant disparity with regard to price or delivery – this would not necessarily be discounted as a negative factor – one supplier may have discovered an item that others overlooked.) 9 Do the concepts promote simplicity and maintainability?

Documentation is sometimes overlooked when acquiring a measurement process. The significance that documentation takes with any successful project is often misunderstood. The usual strategy behind documentation is to provide an original set of mechanical and electrical designs (CAD or hardcopy drawings) for the measurement process hardware at the time of delivery. This may satisfy initial implementation requirements, but this documentation does nothing with regard to defining potential wear points, suggesting possible trouble areas or describing how to use the process. Thus,

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Chapter I – Section D Measurement Source Development

the required documentation for any process ought to include more than assembly and detailed drawings of the measurement equipment. Effective documentation for any system serves the same purpose as a good map on a trip. For example, it will suggest to the user how to get from one point to another (user instructions or gage instructions). It provides the user with possible alternative routes to reach the desired destinations (troubleshooting guides or diagnostic trees) if the main route is blocked or closed. A complete documentation package may include: x x

x x x x

x

x

x

Reproducible set of assembly and detailed mechanical drawings (CAD or hardcopy) (including any required masters) Reproducible set of electrical hard-wiring, logic and software Suggested spare parts list of heavy use or wear items/details. This list should include items that may require considerable leadtime to acquire Maintenance manuals with machine drawing cutaways and steps to properly assemble and disassemble machine components Manuals defining utility requirements for setup and operation and machine transport requirements (e.g., load bearing members) Diagnostic trees and a troubleshooting guide Certification reports (traceable to NIST where applicable) Calibration instructions User manuals that can be used by the technical support personnel, the system operator and maintenance personnel

The above list can be used as a checklist when organizing the quotation package; however it is not necessarily all-inclusive. The central theme here is communication. Since documentation is a form of communication, the team and others ought to be involved at every level of the development of the measurement process documentation package.

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Chapter I – Section D Measurement Source Development

Qualification at the Supplier

The gage or measurement system should be given a full dimensional layout and functional test, where applicable, at the measurement system supplier before shipment. Obviously, the chosen supplier must have qualified measurement equipment and personnel on site in order to accomplish this. If not, pre-arrangements should have been made to have this work done at an outside independent qualified laboratory. Results of such dimensional layout and/or testing should be done in accordance with customer design and build standards and be fully documented and available for customer review. After successful dimensional layout, the supplier should perform a preliminary but formal measurement systems analysis. This again prerequires that the supplier have the personnel, knowledge and experience to accomplish the appropriate analysis. The customer should predetermine with the supplier (and perhaps the OEM) exactly what sort of analysis is required at this point and should be aware of any guidance the supplier might need. Some issues that may need discussion, negotiation or common agreement are: x

Objective of the preliminary MSA study :

9 Gage repeatability (GR 16 ) versus gage repeatability and reproducibility (GRR) 9 Assessment of bias and/or linearity 9 Assessment of the customer purpose for measurement P

x

Quantity of pieces, trials and operators in study

x

Use of supplier personnel vs. customer supplied personnel

x

Shipment

9 Acceptance criteria

Necessary training for personnel

9 Are they qualified? 9 Do they understand intent? 9 What software might be used?Whatever results are achieved at this point in time, it should be realized that these are merely preliminary and judgment may be needed as to the acceptability of the results.

CHECKLIST x x

When should the equipment be shipped?

x

Who removes equipment from the truck or rail car?

x

Should documentation be shipped with the hardware?

x

How should it be shipped?

x

Is insurance required?

x 16

F

Does the customer have the proper equipment to unload the hardware? Where will the system be stored until shipment?

See Appendix D.

35

Chapter I – Section D Measurement Source Development

x

x

Qualification at the Customer

Where will the system be stored until implementation? Is the shipping documentation complete and easily understandable for the loader, transporter, unloader and installation crew?

Generally, what was done to qualify the measurement system above at the supplier before shipment should be repeated in some manner at the customer once delivery is completed. Since this becomes the first real opportunity to study the measurement system in its intended environment, acceptance standards and analysis methods used here should be considered seriously. Attention to detail on the part of all parties involved is paramount to the eventual success of this measurement system and the use of the data it generates. Before any measurement analysis is begun after receipt, the measurement system should undergo a full dimensional layout to confirm it meets build requirements/standards. The extent of this layout may be balanced against layout work done previously at the measurement system supplier before shipment and confidence in the quality of the layout results done at the supplier as well as the lack of potential shipping damage. When comparing results before and after shipment, be aware that there will likely be some differences in these measurements because of differences in these measurement systems.

Documentation Delivery

The information that is required, at a minimum, to aid implementation and startup of any system is the following: (This information ought to be delivered to the customer prior to delivery.) x x

x

x x

CAD or hardcopy drawings, if required by team Process flow diagram of the system, where applicable User manuals

9 Maintenance/service manual 9 Spare parts list 9 Troubleshooting guide Calibration instructions Any special considerations

At the outset, the delivered documentation needs to be noted as preliminary. Original or reproducible documentation does not need to be delivered at this time because potential revision may be necessary after implementation. In fact, it is a wise idea to not have the original documentation package delivered until after the entire system is implemented – suppliers are generally more efficient with updating documentation than customers.

36

Chapter I – Section D Measurement Source Development

Suggested Elements for a Measurement System Development Checklist This list should be modified based on the situation and type of measurement system. The development of the final checklist should be the result of collaboration between the customer and supplier. Measurement System Design and Development Issues: ‰ ‰

‰ ‰ ‰ ‰ ‰

‰

‰

‰

What is to be measured? What type of characteristic is it? Is it a mechanical property? Is it dynamic or stationary? Is it an electrical property? Is there significant within-part variation? For what purpose will the results (output) of the measurement process be used? Production improvement, production monitoring, laboratory studies, process audits, shipping inspection, receiving inspection, responses to a D.O.E.? Who will use the process? Operators, engineers, technicians, inspectors, auditors? Training required: Operator, maintenance personnel, engineers; classroom, practical application, OJT, apprenticeship period. Have the sources of variation been identified? Build an error model (S.W.I.P.E. or P.I.S.M.O.E.A.) using teams, brainstorming, profound process knowledge, cause & effect diagram or matrix. Has a FMEA been developed for the measurement system? Flexible vs. dedicated measurement systems: Measurement systems can either be permanent and dedicated or they can be flexible and have the ability to measure different types of parts; e.g., doghouse gages, fixture gaging, coordinate measurement machine, etc. Flexible gaging will be more expensive, but can save money in the long run. Contact vs. non-contact: Reliability, type of feature, sample plan, cost, maintenance, calibration, personnel skill required, compatibility, environment, pace, probe types, part deflection, image processing . This may be determined by the control plan requirements and the frequency of the measurement ( Full contact gaging may get excessive wear during continuous sampling). Full surface contact probes, probe type, air feedback jets, image processing, CMM vs. optical comparator, etc. Environment: Dirt, moisture, humidity, temperature, vibration, noise, electro-magnetic interference (EMI), ambient air movement, air contaminants, etc. Laboratory, shop floor, office, etc? Environment becomes a key issue with low, tight tolerances in the micron level. Also, in cases that CMM, vision systems, ultrasonic, etc. This could be a factor in auto-feedback in-process type measurements. Cutting oils, cutting debris, and extreme temperatures could also become issues. Is a clean room required? Measurement and location points: Clearly define, using GD&T, the location of fixturing and clamping points and where on the part the measurements will be taken.

‰

Fixturing method: Free state versus clamped part holding.

‰

Part orientation: Body position versus other.

‰ ‰

Part preparation: Should the part be clean, non-oily, temperature stabilized, etc. before measurement? Transducer location: Angular orientation, distance from primary locators or nets.

37

Chapter I – Section D Measurement Source Development ‰

‰

‰ ‰

‰ ‰ ‰

Correlation issue #1 – duplicate gaging: Are duplicate (or more) gages required within or between plants to support requirements? Building considerations, measurement error considerations, maintenance considerations. Which is considered the standard? How will each be qualified? Correlations issue #2 – methods divergence: Measurement variation resulting from different measurement system designs performing on the same product/process within accepted practice and operation limits (e.g., CMM versus manual or open-setup measurement results). Automated vs. manual: on-line, off-line, operator dependencies. Destructive versus nondestructive measurement (NDT): Examples: tensile test, salt spray testing, plating/paint coating thickness, hardness, dimensional measurement, image processing, chemical analysis, stress, durability, impact, torsion, torque, weld strength, electrical properties, etc. Potential measurement range: size and expected range of conceivable measurements. Effective resolution: Is measurement sensitive to physical change (ability to detect process or product variation) for a particular application acceptable for the application? Sensitivity: Is the size of the smallest input signal that results in a detectable (discernable) output signal for this measurement device acceptable for the application? Sensitivity is determined by inherent gage design and quality (OEM), in-service maintenance, and operating condition.

Measurement System Build Issues (equipment, standard, instrument): ‰ ‰ ‰

Have the sources of variation identified in the system design been addressed? Design review; verify and validate. Calibration and control system: Recommended calibration schedule and audit of equipment and documentation. Frequency, internal or external, parameters, in-process verification checks. Input requirements: Mechanical, electrical, hydraulic, pneumatic, surge suppressors, dryers, filters, setup and operation issues, isolation, discrimination and sensitivity.

‰

Output requirements: Analog or digital, documentation and records, file, storage, retrieval, backup.

‰

Cost: Budget factors for development, purchase, installation, operation and training.

‰

Preventive maintenance: Type, schedule, cost, personnel, training, documentation.

‰ ‰ ‰ ‰ ‰ ‰

Serviceability: Internal and external, location, support level, response time, availability of service parts, standard parts list. Ergonomics: Ability to load and operate the machine without injuries over time. Measurement device discussions need to focus on issues of how the measurement system is interdependent with the operator. Safety considerations: Personnel, operation, environmental, lock-out. Storage and location: Establish the requirements around the storage and location of the measurement equipment. Enclosures, environment, security, availability (proximity) issues. Measurement cycle time: How long will it take to measure one part or characteristic? Measurement cycle integrated to process and product control. Will there be any disruption to process flow, lot integrity, to capture, measure and return the part?

38

Chapter I – Section D Measurement Source Development ‰ ‰

‰ ‰

‰ ‰ ‰

‰

‰

Material handling: Are special racks, holding fixtures, transport equipment or other material handling equipment needed to deal with parts to be measured or the measurement system itself? Environmental issues: Are there any special environmental requirements, conditions, limitations, either affecting this measurement process or neighboring processes? Is special exhausting required? Is temperature or humidity control necessary? Humidity, vibration, noise, EMI, cleanliness. Are there any special reliability requirements or considerations? Will the equipment hold up over time? Does this need to be verified ahead of production use? Spare parts: Common list, adequate supply and ordering system in place, availability, lead-times understood and accounted for. Is adequate and secure storage available? (bearings, hoses, belts, switches, solenoids, valves, etc.) User instructions: Clamping sequence, cleaning procedures, data interpretation, graphics, visual aids, comprehensive. Available, appropriately displayed. Documentation: Engineering drawings, diagnostic trees, user manuals, language, etc. Calibration: Comparison to acceptable standards. Availability and cost of acceptable standards. Recommended frequency, training requirements. Down-time required? Storage: Are there any special requirements or considerations regarding the storage of the measurement device? Enclosures, environment, security from damage/theft, etc. Error/Mistake proofing: Can known measurement procedure mistakes be corrected easily (too easily?) by the user? Data entry, misuse of equipment, error proofing, mistake proofing.

Measurement System Implementation Issues (process): ‰ ‰

‰

‰ ‰

‰ ‰

Support: Who will support the measurement process? Lab technicians, engineers, production, maintenance, outside contracted service? Training: What training will be needed for operators/inspectors/technicians/engineers to use and maintain this measurement process? Timing, resource and cost issues. Who will train? Where will training be held? Leadtime requirements? Coordinated with actual use of measurement process. Data management: How will data output from this measurement process be managed? Manual, computerized, summary methods, summary frequency, review methods, review frequency, customer requirements, internal requirements. Availability, storage, retrieval, backup, security. Data interpretation. Personnel: Will personnel need to be hired to support this measurement process? Cost, timing, availability issues. Current or new. Improvement methods: Who will improve the measurement process over time? Engineers, production, maintenance, quality personnel? What evaluation methods will be used? Is there a system to identify needed improvements? Long-term stability: Assessment methods, format, frequency, and need for long-term studies. Drift, wear, contamination, operational integrity. Can this long-term error be measured, controlled, understood, predicted? Special considerations: Inspector attributes, physical limitations or health issues: colorblindness, vision, strength, fatigue, stamina, ergonomics.

39

Chapter I – Section D Measurement Source Development

40

Chapter I – Section E Measurement Issues

Section E Measurement Issues Three fundamental issues must be addressed when evaluating a measurement system: 1) The measurement system must demonstrate adequate sensitivity.

9 First, does the instrument (and standard) have adequate discrimination? Discrimination (or class) is fixed by design and serves as the basic starting point for selecting a measurement system. Typically, the Rule of Tens has been applied, which states that instrument discrimination should divide the tolerance (or process variation) into ten parts or more. 9 Second, does the measurement system demonstrate effective resolution? Related to discrimination, determine if the measurement system has the sensitivity to detect changes in product or process variation for the application and conditions.

2) The measurement system must be stable.

9 Under repeatability conditions, the measurement system variation is due to common causes only and not special (chaotic) causes. 9 The measurement analyst must always consider practical and statistical significance.

3) The statistical properties (errors) are consistent over the expected range and adequate for the purpose of measurement (product control or process control). The long-standing tradition of reporting measurement error only as a percent of tolerance is inadequate for the challenges of the marketplace that emphasize strategic and continuous process improvement. As processes change and improve, a measurement system must be re-evaluated for its intended purpose. It is essential for the organization (management, measurement planner, production operator, and quality analyst) to understand the purpose of measurement and apply the appropriate evaluation.

41

Chapter I – Section E Measurement Issues

Types of Measurement System Variation

It is often assumed that measurements are exact, and frequently the analysis and conclusions are based upon this assumption. An individual may fail to realize there is variation in the measurement system which affects the individual measurements, and subsequently, the decisions based upon the data. Measurement system error can be classified into five categories: bias, repeatability, reproducibility, stability and linearity. One of the objectives of a measurement system study is to obtain information relative to the amount and types of measurement variation associated with a measurement system when it interacts with its environment. This information is valuable, since for the average production process, it is far more practical to recognize repeatability and calibration bias and establish reasonable limits for these, than to provide extremely accurate gages with very high repeatability. Applications of such a study provide the following: x

x

A criterion to accept new measuring equipment

x

A basis for evaluating a gage suspected of being deficient

x

A comparison of one measuring device against another

x

A comparison for measuring equipment before and after repair

x

A required component for calculating process variation, and the acceptability level for a production process Information necessary to develop a Gage Performance Curve (GPC), 17 which indicates the probability of accepting a part of some true value P

F

The following definitions help describe the types of error or variation associated with a measurement system, so that each term is clearly understood for subsequent discussion. An illustration is given for each definition which graphically displays the meaning of each term.

17

See Chapter V, Section C.

42

Chapter I – Section E Measurement Issues

Operational Definition Definitions and Potential Sources of Variation

“An operational definition is one that people can do business with. An operational definition of safe, round, reliable, or any other quality [characteristic] must be communicable, with the same meaning to vendor as to the purchaser, same meaning yesterday and today to the production worker. Example: 1) A specific test of a piece of material or an assembly 2) A criterion (or criteria) for judgment 3) Decision: yes or no, the object or the material did or did not meet the criterion (or criteria)” FP18

Standard A standard is anything taken by general consent as a basis for comparison; an accepted model. It can be an artifact or ensemble (instruments, procedures, etc.) set up and established by an authority as a rule for the measure of quantity, weight, extent, value or quality. The concept of ensemble was formalized in ANSI/ASQC Standard M11996. 19 This term was used to stress the fact that all of the influences affecting the measurement uncertainty need to be taken into account; e.g., environment, procedures, personnel, etc. “An example of a simple ensemble would be an ensemble for the calibration of gage blocks consisting of a standard gage block, a comparator, an operator, environment, and the calibration procedure.” P

F

Reference Standards A standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived. Measurement and Test Equipment (M&TE) All of the measurement instruments, measurement standards, reference materials, and auxiliary apparatus that are necessary to perform a measurement. Calibration Standard A standard that serves as a reference in the performance of routine calibrations. Intended to act as a buffer between the calibration workload and the laboratory’s reference standard(s).

18 19

W. E. Deming, Out of the Crisis (1982, 1986), p. 277. This definition was later updated as Measurement and Test Equipment or M&TE by subsequent military standards.

43

Chapter I – Section E Measurement Issues

Transfer Standard A standard used to compare a separate standard of known value to the unit being calibrated. Master A standard used as a reference in a calibration process. May also be termed as reference or calibration standard. Working Standard A standard whose intended use is to perform routine measurements within the laboratory, not intended as a calibration standard, but may be utilized as a transfer standard. Careful consideration needs to be given to the material(s) selected for a standard. The materials employed ought to reflect the use and scope of the measurement system, as well as time-based sources of variation such as wear and environmental factors (temperature, humidity, etc.).

Measurement & Test Equipment

Reference Standard

Master

Transfer Standard

Calibration Standard

Master

Transfer Standard

Working Standard Check Standard

Figure I-E 1: Relationships among the Various Standards

44

Chapter I – Section E Measurement Issues

Check Standard A measurement artifact that closely resembles what the process is designed to measure, but is inherently more stable than the measurement process being evaluated. Reference Value A reference value, also known as the accepted reference value or master value, is a value of an artifact or ensemble that serves as an agreed upon reference for comparison. Accepted reference values are based upon the following: x

x x

x x x

Determined by averaging several measurements with a higher level (e.g., metrology lab or layout equipment) of measuring equipment Legal values: defined and mandated by law Theoretical values: based on scientific principles Assigned values: based on experimental work (supported by sound theory) of some national or international organization Consensus values: based on collaborative experimental work under the auspices of a scientific or engineering group; defined by a consensus of users such as professional and trade organizations Agreement values: values expressly agreed upon by the affected parties

In all cases, the reference value needs to be based upon an operational definition and the results of an acceptable measurement system. To achieve this, the measuring system used to determine the reference value should include: x x

Instrument(s) with a higher order discrimination and a lower measurement system error than the systems used for normal evaluation Be calibrated with standards traceable to the NIST or other NMI

True Value The true value is the “actual” measure of the part. Although this value is unknown and unknowable, it is the target of the measurement process. Any individual reading ought to be as close to this value as (economically) possible. Unfortunately, the true value can never be known with certainty. The reference value is used as the best approximation of the true value in all analyses. Because the reference value is used as a surrogate for the true value, these terms are commonly used interchangeably. This usage is not recommended. 20 P

20

F

See also ASTM E177-90a.

45

Chapter I – Section E Measurement Issues

Discrimination Discrimination is the amount of change from a reference value that an instrument can detect and faithfully indicate. This is also referred to as readability or resolution. The measure of this ability is typically the value of the smallest graduation on the scale of the instrument. If the instrument has “coarse” graduations, then a half-graduation can be used. A general rule of thumb is the measuring instrument discrimination ought to be at least one-tenth of the range to be measured. Traditionally this range has been taken to be the product specification. Recently the 10 to 1 rule is being interpreted to mean that the measuring equipment is able to discriminate to at least one-tenth of the process variation. This is consistent with the philosophy of continual improvement (i.e., the process focus is a customer designated target).

full interval

half interval

Figure I-E 2: Discrimination The above rule of thumb can be considered as a starting point to determine the discrimination since it does not include any other element of the measurement system’s variability. Because of economic and physical limitations, the measurement system will not perceive all parts of a process distribution as having separate or different measured characteristics. Instead the measured characteristic will be grouped by the measured values into data categories. All parts in the same data category will have the same value for the measured characteristic. If the measurement system lacks discrimination (sensitivity or effective resolution), it may not be an appropriate system to identify the process variation or quantify individual part characteristic values. If that is the case, better measurement techniques should be used. The discrimination is unacceptable for analysis if it cannot detect the variation of the process, and unacceptable for control if it cannot detect the special cause variation (See Figure I-E 3).

46

Chapter I – Section E Measurement Issues

Number of Categories

1 Data Category

2 - 4 Data Categories

Control

Analysis

Can be used for control only if: x The process variation is small when compared to the specifications x The loss function is flat over the expected process variation x The main source of variation causes a mean shift

x Unacceptable for estimating process parameters and indices x Only indicates whether the process is producing conforming or nonconforming parts

x Can be used with semivariable control techniques based on the process distribution x Can produce insensitive variables control charts

x Generally unacceptable for estimating process parameters and indices since it only provides coarse estimates

x Can be used with variables control charts

x Recommended

5 or more Data Categories Figure I-E 3: Impact of Number of Distinct Categories (ndc) of the Process Distribution on Control and Analysis Activities Symptoms of inadequate discrimination may appear in the range chart. Figure I-E 4 contains two sets of control charts derived from the same data. Control Chart (a) shows the original measurement to the nearest thousandth of an inch. Control Chart (b) shows these data rounded off to the nearest hundredth of an inch. Control Chart (b) appears to be out of control due to the artificially tight limits. The zero ranges are more a product of the rounding off than they are an indication of the subgroup variation. A good indication of inadequate discrimination can be seen on the SPC range chart for process variation. In particular, when the range chart shows only one, two, or three possible values for the range within the control limits, the measurements are being made with inadequate discrimination. Also, if the range chart shows four possible values for the range within control limits and more than one-fourth of the ranges are zero, then the measurements are being made with inadequate discrimination. Another good indication of inadequate discrimination is on a normal probability plot where the data will be stacked into buckets instead of flowing along the 45 degree line.

47

Chapter I – Section E Measurement Issues

Returning to Figure I-E 4, Control Chart (b), there are only two possible values for the range within the control limits (values of 0.00 and 0.01). Therefore, the rule correctly identifies the reason for the lack of control as inadequate discrimination (sensitivity or effective resolution). This problem can be remedied, of course, by changing the ability to detect the variation within the subgroups by increasing the discrimination of the measurements. A measurement system will have adequate discrimination if its apparent resolution is small relative to the process variation. Thus a recommendation for adequate discrimination would be for the apparent resolution to be at most one-tenth of total process six sigma standard deviation instead of the traditional rule which is the apparent resolution be at most one-tenth of the tolerance spread. Eventually, there are situations that reach a stable, highly capable process using a stable, “best-in-class” measurement system at the practical limits of technology. Effective resolution may be inadequate and further improvement of the measurement system becomes impractical. In these special cases, measurement planning may require alternative process monitoring techniques. Customer approval will typically be required for the alternative process monitoring technique.

48

Chapter I – Section E Measurement Issues

Xbar/R Chart Discrimination = .001 Sample Mean

0.145

A

UCL=0.1444

0.140

Mean=0.1397

0.135

LCL=0.1350

Subgroup

0

5

10

15

20

25

Sample Range

0.02 UCL=0.01717

0.01

R=0.00812

LCL=0

0.00

Xbar/R Chart Discrimination = .01 0.145

Sample Mean

UCL=0.1438

B

0.140

Mean=0.1398

LCL=0.1359

0.135

Subgroup

0

5

10

15

20

25

Sample Range

0.02 UCL=0.01438 0.01 R=0.0068 LCL=0

0.00

Figure I-E 4: Process Control Charts 21 P

21

Figure I-E 4 was developed using data from Evaluating The Measurement Process, by Wheeler and Lyday, Copyright 1989, SPC Press, Inc., Knoxville, Tennessee.

49

Chapter I – Section E Measurement Issues

Measurement Process Variation

For most measurement processes, the total measurement variation is usually described as a normal distribution. Normal probability is an assumption of the standard methods of measurement systems analysis. In fact, there are measurement systems that are not normally distributed. When this happens, and normality is assumed, the MSA method may overestimate the measurement system error. The measurement analyst must recognize and correct evaluations for non-normal measurement systems.

Location Width Figure I-E 5: Characteristics of the Measurement Process Variation

Accuracy

Location Variation

Accuracy is a generic concept of exactness related to the closeness of agreement between the average of one or more measured results and a reference value. The measurement process must be in a state of statistical control, otherwise the accuracy of the process has no meaning. In some organizations accuracy is used interchangeably with bias. The ISO (International Organization for Standardization) and the ASTM (American Society for Testing and Materials) use the term accuracy to embrace both bias and repeatability. In order to avoid confusion which could result from using the word accuracy, ASTM recommends that only the term bias be used as the descriptor of location error. This policy will be followed in this text. Bias Bias is often referred to as “accuracy.” Because “accuracy” has several meanings in literature, its use as an alternate for “bias” is not recommended.

50

Chapter I – Section E Measurement Issues

Bias is the difference between the true value (reference value) and the observed average of measurements on the same characteristic on the same part. Bias is the measure of the systematic error of the measurement system. It is the contribution to the total error comprised of the combined effects of all sources of variation, known or unknown, whose contributions to the total error tends to offset consistently and predictably all results of repeated applications of the same measurement process at the time of the measurements.

Possible causes for excessive bias are: x

x

Instrument needs calibration

x

Worn or damaged master, error in master

x

Poor quality instrument – design or conformance

x

Wrong gage for the application

x

Measuring the wrong characteristic

x

Environment – temperature, humidity, vibration, cleanliness

x

Worn instrument, equipment or fixture

x

Improper calibration or use of the setting master

x

Linearity error

x

Different measurement method – setup, loading, clamping, technique

x

Distortion (gage or part)

x

Violation of an assumption, error in an applied constant Application – part size, position, operator skill, fatigue, observation error (readability, parallax)

The measurement procedure employed in the calibration process (i.e., using "masters") should be as identical as possible to the normal operation's measurement procedure.

51

Chapter I – Section E Measurement Issues

Stability Stability (or drift) is the total variation in the measurements obtained with a measurement system on the same master or parts when measuring a single characteristic over an extended time period. That is, stability is the change in bias over time. Time

Reference Value

Possible causes for instability include: x

x x x x

Instrument needs calibration, reduce the calibration interval Worn instrument, equipment or fixture Normal aging or obsolescence Poor maintenance – air, power, hydraulic, filters, corrosion, rust, cleanliness

x

Worn or damaged master, error in master

x

Poor quality instrument – design or conformance

x

Different measurement method – setup, loading, clamping, technique

x

Environmental drift – temperature, humidity, vibration, cleanliness

x

Improper calibration or use of the setting master

x

Instrument design or method lacks robustness

x

Distortion (gage or part)

x

Violation of an assumption, error in an applied constant Application – part size, position, operator skill, fatigue, observation error (readability, parallax)

Linearity The difference of bias throughout the expected operating (measurement) range of the equipment is called linearity. Linearity can be thought of as a change of bias with respect to size.

52

Chapter I – Section E Measurement Issues

BIAS BIAS

Value 1

Value N

Note that unacceptable linearity can come in a variety of flavors. Do not assume a constant bias.

Possible causes for linearity error include: x

x

x x

Instrument needs calibration, reduce the calibration interval Worn instrument, equipment or fixture Poor maintenance – air, power, hydraulic, filters, corrosion, rust, cleanliness Worn or damaged master(s), error in master(s) – minimum/ maximum

53

Chapter I – Section E Measurement Issues

x x

Width Variation

Improper calibration (not covering the operating range) or use of the setting master(s)

x

Poor quality instrument – design or conformance

x

Wrong gage for the application

x

Distortion (gage or part) changes with part size

x

Violation of an assumption, error in an applied constant

x

Instrument design or method lacks robustness

x

Different measurement method – setup, loading, clamping, technique

x

Environment – temperature, humidity, vibration, cleanliness

Application – part size, position, operator skill, fatigue, observation error (readability, parallax)

Precision Traditionally, precision describes the net effect of discrimination, sensitivity and repeatability over the operating range (size, range and time) of the measurement system. In some organizations precision is used interchangeably with repeatability. In fact, precision is most often used to describe the expected variation of repeated measurements over the range of measurement; that range may be size or time (i.e., “a device is as precise at the low range as high range of measurement”, or “as precise today as yesterday”). One could say precision is to repeatability what linearity is to bias (although the first is random and the other systematic errors). The ASTM defines precision in a broader sense to include the variation from different readings, gages, people, labs or conditions.

Repeatability Reference Value

Repeatability

This is traditionally referred to as the "within appraiser" variability. Repeatability is the variation in measurements obtained with one measurement instrument when used several times by one appraiser while measuring the identical characteristic on the same part. This is the inherent variation or capability of the equipment itself. Repeatability is commonly referred to as equipment variation (EV), although this is misleading. In fact, repeatability is the common cause (random error) variation from successive trials under defined conditions of measurement. The best term for repeatability is within-system variation when the conditions of measurement are fixed and defined – fixed part, instrument, standard, method, operator, environment, and assumptions. In addition to within-equipment variation, repeatability will include all within variation (see below) from any condition in the error model.

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Chapter I – Section E Measurement Issues

Possible causes for poor repeatability include: x

x x x x x x

x

Within-part (sample): form, position, surface finish, taper, sample consistency Within-instrument: repair; wear, equipment or fixture failure, poor quality or maintenance Within-standard: quality, class, wear Within-method: variation in setup, technique, zeroing, holding, clamping Within-appraiser: technique, position, manipulation skill or training, feel, fatigue

lack

Within-environment: short-cycle fluctuations humidity, vibration, lighting, cleanliness

of in

experience, temperature,

Violation of an assumption – stable, proper operation

x

Instrument design or method lacks robustness, poor uniformity

x

Distortion (gage or part), lack of rigidity

x

Wrong gage for the application

Application – part size, position, observation error (readability, parallax)

Reproducibility This is traditionally referred to as the "between appraisers" variability. Reproducibility is typically defined as the variation in the average of the measurements made by different appraisers using the same measuring instrument when measuring the identical characteristic on the same part. This is often true for manual instruments influenced by the skill of the operator. It is not true, however, for measurement processes (i.e., automated systems) where the operator is not a major source of variation. For this reason, reproducibility is referred to as the average variation betweensystems or between-conditions of measurement. The ASTM definition goes beyond this to potentially include not only different appraisers but also different: gages, labs and environment (temperature, humidity) as well as including repeatability in the calculation of reproducibility.

Reproducibility

Appraiser

A

C

B

55

Chapter I – Section E Measurement Issues

Potential sources of reproducibility error include: x

x

x x x

x

x

Between-parts (samples): average difference when measuring types of parts A, B, C, etc, using the same instrument, operators, and method. Between-instruments: average difference using instruments A, B, C, etc., for the same parts, operators and environment. Note: in this study reproducibility error is often confounded with the method and/or operator. Between-standards: average influence of different setting standards in the measurement process. Between-methods: average difference caused by changing point densities, manual versus automated systems, zeroing, holding or clamping methods, etc. Between-appraisers (operators): average difference between appraisers A, B, C, etc., caused by training, technique, skill and experience. This is the recommended study for product and process qualification and a manual measuring instrument. Between-environment: average difference in measurements over time 1, 2, 3, etc. caused by environmental cycles; this is the most common study for highly automated systems in product and process qualifications.

x

Violation of an assumption in the study

x

Operator training effectiveness

x

Instrument design or method lacks robustness

Application – part size, position, observation error (readability, parallax) As mentioned in the two definitions above, there are differences in the definitions used by ASTM and those used by this manual. The ASTM literature focuses on interlaboratory evaluations with interest on laboratory-to-laboratory differences including the potential for different operators, gages and environment as well as within laboratory repeatability. Therefore, ASTM definitions need to encompass these differences. By ASTM standards, repeatability is the best the equipment will be under current conditions (one operator, one gage, short period of time) and reproducibility represents more typical operating conditions where there is variation from multiple sources.

Gage R&R or GRR Gage R&R is an estimate of the combined variation of repeatability and reproducibility. Stated another way, GRR is the variance equal to the sum of within-system and between-system variances.

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Chapter I – Section E Measurement Issues 2 V GRR

2 2 V reproducibility  V repeatability Reference Value

A

C

B

GRR Sensitivity Sensitivity is the smallest input that results in a detectable (usable) output signal. It is the responsiveness of the measurement system to changes in measured feature. Sensitivity is determined by gage design (discrimination), inherent quality (OEM), in-service maintenance, and the operating condition of the instrument and standard. It is always reported as a unit of measure. Factors that affect sensitivity include: x x

Ability to dampen an instrument

x

Repeatability of the measuring device

x x

Skill of operator

Ability to provide drift free operation in the case of electronic or pneumatic gages Conditions under which the instrument is being used such as ambient air, dirt, humidity

Consistency Consistency is the difference in the variation of the measurements taken over time. It may be viewed as repeatability over time.

Factors impacting consistency are special causes of variation such as: x x x

Temperature of parts Warm up required for electronic equipment Worn equipment

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Chapter I – Section E Measurement Issues

Uniformity Uniformity is the difference in variation throughout the operating range of the gage. It may be considered to be the homogeneity (sameness) of the repeatability over size. Factors impacting uniformity include: x

x x

Measurement System Variation

Fixture allows smaller/larger sizes to position differently Poor readability on the scale Parallax in reading

Capability The capability of a measurement system is an estimate of the combined variation of measurement errors (random and systematic) based on a shortterm assessment. Simple capability includes the components of: x

x

Uncorrected bias or linearity Repeatability and reproducibility (GRR), including short-term consistency

Refer to Chapter III for typical methods and examples to quantify each component. An estimate of measurement capability, therefore, is an expression of the expected error for defined conditions, scope and range of the measurement system (unlike measurement uncertainty, which is an expression of the expected range of error or values associated with a measurement result). The capability expression of combined variation (variance) when the measurement errors are uncorrelated (random and independent) can be quantified as:

V

2 capability

V

2 bias ( linearity )

V

2 GRR

There are two essential points to understand and correctly apply measurement capability: First, an estimate of capability is always associated with a defined scope of measurement – conditions, range and time. For example, to say that the capability of a 25 mm micrometer is 0.1 mm is incomplete without qualifying the scope and range of measurement conditions. Again, this is why an error model to define the measurement process is so important. The scope for an estimate of measurement capability could be very specific or a general statement of operation, over a limited portion or entire measurement range. Short-term could mean: the capability over a series of measurement cycles, the time to complete the GRR evaluation, a specified period of

58

Chapter I – Section E Measurement Issues

production, or time represented by the calibration frequency. A statement of measurement capability need only be as complete as to reasonably replicate the conditions and range of measurement. A documented Control Plan could serve this purpose. Second, short-term consistency and uniformity (repeatability errors) over the range of measurement are included in a capability estimate. For a simple instrument, such as a 25 mm micrometer, the repeatability over the entire range of measurement using typical, skilled operators is expected to be consistent and uniform. In this example, a capability estimate may include the entire range of measurement for multiple types of features under general conditions. Longer range or more complex measurement systems (i.e., a CMM) may demonstrate measurement errors of (uncorrected) linearity, uniformity, and short-term consistency over range or size. Because these errors are correlated they cannot be combined using the simple linear formula above. When (uncorrected) linearity, uniformity or consistency varies significantly over range, the measurement planner and analyst has only two practical choices: 1) Report the maximum (worst case) capability for the entire defined conditions, scope and range of the measurement system, or 2) Determine and report multiple capability assessments for defined portions of the measurement range (i.e., low, mid, larger range). Performance As with process performance, measurement system performance is the net effect of all significant and determinable sources of variation over time. Performance quantifies the long-term assessment of combined measurement errors (random and systematic). Therefore, performance includes the longterm error components of: x

x

Capability (short-term errors) Stability and consistency

Refer to Chapter III for typical methods and examples to quantify each component. An estimate of measurement performance is an expression of the expected error for defined conditions, scope and range of the measurement system (unlike measurement uncertainty, which is an expression of the expected range of error or values associated with a measurement result). The performance expression of combined variation (variance) when the measurement errors are uncorrelated (random and independent) can be quantified as:

V

2 performanc e

V

2 capability

59

V

2 stability

V

2 consistenc y

Chapter I – Section E Measurement Issues

Again, just as short-term capability, long-term performance is always associated with a defined scope of measurement – conditions, range and time. The scope for an estimate of measurement performance could be very specific or a general statement of operation, over a limited portion or entire measurement range. Long-term could mean: the average of several capability assessments over time, the long-term average error from a measurement control chart, an assessment of calibration records or multiple linearity studies, or average error from several GRR studies over the life and range of the measurement system. A statement of measurement performance need only be as complete as to reasonably represent the conditions and range of measurement. Long-term consistency and uniformity (repeatability errors) over the range of measurement are included in a performance estimate. The measurement analyst must be aware of potential correlation of errors so as to not overestimate the performance estimate. This depends on how the component errors were determined. When long-term (uncorrected) linearity, uniformity or consistency vary significantly over the range, the measurement planner and analyst has only two practical choices: 1) Report the maximum (worst case) performance for the entire defined conditions, scope and range of the measurement system, or 2) Determine and report multiple performance assessments for a defined portion of the measurement range (i.e., low, mid, larger range).

Uncertainty Measurement uncertainty is defined by VIM as a “parameter, associated with the result of a measurement, that characteristics the dispersion of the values that could reasonably be attributed to the measurand.” 22 See Chapter I, Section F, for more detail. P

Comments

F

Of a measurement system’s parameters, accuracy and precision are most familiar to operating personnel since they are used in everyday life as well as technical and sales discussions. Unfortunately, these terms are also the most fuzzy as they are often thought of interchangeably. For example, if the gage is certified by an independent agency as accurate, or if the instrument is guaranteed to have high precision by the vendor, then it is incorrectly thought that all readings will fall very close to the actual values. This is not only conceptually wrong but can lead to wrong decisions about the product and process. This ambiguity carries over to bias and repeatability (as measures of accuracy and precision). It is important to realize that:

22

Measurand is then defined by the VIM as “the particular quantity subject to measurement”.

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Chapter I – Section E Measurement Issues

x x

Bias and repeatability are independent of each other (See Figure I-E 6). Controlling one of these sources of error does not guarantee the control of the other. Consequently, measurement systems control programs (traditionally referred to as Gage Control Programs) ought to quantify and track all relevant sources of variation. 23 P

23

See also Chapter I, Section B.

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Chapter I – Section E Measurement Issues

Figure I-E 6: Relationships between Bias and Repeatability

62

Chapter I – Section F Measurement Uncertainty

Section F Measurement Uncertainty Measurement Uncertainty is a term that is used internationally to describe the quality of a measurement value. While this term has traditionally been reserved for many of the high accuracy measurements performed in metrology or gage laboratories, many customer and quality system standards require that measurement uncertainty be known and consistent with required measurement capability of any inspection, measuring or test equipment. In essence, uncertainty is the value assigned to a measurement result that describes, within a defined level of confidence, the range expected to contain the true measurement result. Measurement uncertainty is normally reported as a bilateral quantity. Uncertainty is a quantified expression of measurement reliability. A simple expression of this concept is:

True measurement = observed measurement (result) r U U is the term for “expanded uncertainty” of the measurand and measurement result. Expanded uncertainty is the combined standard error (u c ), or standard deviation of the combined errors (random and systematic), in the measurement process multiplied by a coverage factor (k) that represents the area of the normal curve for a desired level of confidence. Remember, a normal distribution is often applied as a principle assumption for measurement systems. The ISO/IEC Guide to the Uncertainty in Measurement establishes the coverage factor as sufficient to report uncertainty at 95% of a normal distribution. This is often interpreted as k = 2.

U

ku c

The combined standard error (u c ) includes all significant components of variation in the measurement process. In most cases, methods of measurement systems analysis performed in accordance with this manual can be used as a tool to quantify many of the sources of measurement uncertainty. Often, the most significant error component can be quantified by V 2performance . Other significant error sources may apply based on the measurement application. An uncertainty statement must include an adequate scope that identifies all significant errors and allows the measurement to be replicated. Some uncertainty statements will build from long-term, others short-term, measurement system error. However, the simple expression can be quantified as: 2 uc2 V 2performance  V other

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Chapter I – Section F Measurement Uncertainty

It is important to remember that measurement uncertainty is simply an estimate of how much a measurement may vary at the time of measurement. It should consider all significant sources of measurement variation in the measurement process plus significant errors of calibration, master standards, method, environment and others not previously considered in the measurement process. In many cases, this estimate will use methods of MSA and GRR to quantify those significant standard errors. It is appropriate to periodically reevaluate uncertainty related to a measurement process to assure the continued accuracy of the estimate.

Measurement Uncertainty and MSA

Measurement Traceability

ISO Guide to the Expression of Uncertainty in Measurement

The major difference between uncertainty and the MSA is that the MSA focus is on understanding the measurement process, determining the amount of error in the process, and assessing the adequacy of the measurement system for product and process control. MSA promotes understanding and improvement (variation reduction). Uncertainty is the range of measurement values, defined by a confidence interval, associated with a measurement result and expected to include the true value of measurement.

Traceability is the property of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties. Therefore understanding the measurement uncertainty of each link in the chain is essential. By including both the short-term and longterm sources of measurement variation that are introduced by the measurement process and the chain of traceability, the measurement system’s measurement uncertainty can be evaluated assuring that all effects of traceability are taken into account. This, in turn, may reduce measurement correlation issues.

The Guide to the Expression of Uncertainty of Measurement (GUM) is a guide to how the uncertainty of a measurement may be evaluated and expressed. While it provides the user with an understanding of the theory and sets guidelines as to how the sources of measurement uncertainty can be classified and combined, it should be considered a high level reference document, not a “how to” manual. It does provide guidance to the user in some of the more advanced topics such as, statistical independence of the sources of variation, sensitivity analysis, degrees of freedom, etc. that are critical when evaluating more complex, multi-parameter measurement systems.

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Chapter I – Section G Measurement Problem Analysis

Section G Measurement Problem Analysis An understanding of measurement variation and the contribution that it makes to total variation needs to be a fundamental step in basic problem solving. When variation in the measurement system exceeds all other variables, it will become necessary to analyze and resolve those issues before working on the rest of the system. In some cases the variation contribution of the measurement system is overlooked or ignored. This may cause loss of time and resources as the focus is made on the process itself, when the reported variation is actually caused by the measurement device. In this section a review will be made on basic problem solving steps and will show how they relate to understanding the issues in a measurement system. Each company may use the problem resolution process which the customer has approved. If the measurement system was developed using the methods in this manual, most of the initial steps will already exist. For example, a cause and effect diagram may already exist giving valuable lessons learned about the measurement process. These data ought to be collected and evaluated prior to any formal problem solving.

Step 1

Step 2

Step 3

Identify the Issues When working with measurement systems, as with any process, it is important to clearly define the problem or issue. In the case of measurement issues, it may take the form of accuracy, variation, stability, etc. The important thing to do is try to isolate the measurement variation and its contribution, from the process variation (the decision may be to work on the process, rather than work on the measurement device). The issue statement needs to be an adequate operational definition that anyone would understand and be able to act on the issue.

Identify the Team The problem solving team, in this case, will be dependent on the complexity of the measurement system and the issue. A simple measurement system may only require a couple of people. But as the system and issue become more complex, the team may grow in size (maximum team size ought to be limited to 10 members). The team members and the function they represent need to be identified on the problem solving sheet.

Flowchart of Measurement System and Process The team would review any historical flowcharting of the measurement system and the process. This would lead to discussion of known and unknown information about the measurement and its interrelationship to the process. The flowcharting process may identify additional members to add to the team.

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Chapter II – Section G Measurement Problem Analysis

Cause and Effect Diagram Step 4

The team would review any historical Cause and Effect Diagram on the Measurement System. This could, in some cases, result in the solution or a partial solution. This would also lead to a discussion on known and unknown information. The team would use subject matter knowledge to initially identify those variables with the largest contribution to the issue. Additional studies can be done to substantiate the decisions.

Plan-Do-Study-Act (PDSA) 24 P

Step 5

This would lead to a Plan-Do-Study-Act, which is form of scientific study. Experiments are planned, data are collected, stability is established, hypotheses are made and proven until an appropriate solution is reached.

Possible Solution and Proof of the Correction Step 6

The steps and solution are documented to record the decision. A preliminary study is performed to validate the solution. This can be done using some form of design of experiment to validate the solution. Also, additional studies can be performed over time including environmental and material variation.

Institutionalize the Change Step 7

24

The final solution is documented in the report; then the appropriate department and functions change the process so that the problem won’t recur in the future. This may require changes in procedures, standards, and training materials. This is one of the most important steps in the process. Most issues and problems have occurred at one time or another.

W. Edwards Deming, The New Economics for Industry, Government, Education, The MIT Press, 1994, 2000

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Chapter II General Concepts for Assessing Measurement Systems

CHAPTER II General Concepts for Assessing Measurement Systems

67

Chapter II General Concepts for Assessing Measurement Systems

68

Chapter II – Section A Background

Section A Background Two important areas need to be assessed: 1) Verify the correct variable is being measured at the proper characteristic location. Verify fixturing and clamping if applicable. Also identify any critical environmental issues that are interdependent with the measurement. If the wrong variable is being measured, then no matter how accurate or how precise the measurement system is, it will simply consume resources without providing benefit. 2) Determine what statistical properties the measurement system needs to have in order to be acceptable. In order to make that determination, it is important to know how the data are to be used, for without that knowledge, the appropriate statistical properties cannot be determined. After the statistical properties have been determined, the measurement system must be assessed to see if it actually possesses these properties or not.

Phase 1 & 2

Understand the measurement process and does it satisfy the requirements?

Phase 1 testing is an assessment to verify the correct variable is being measured at the proper characteristic location per measurement system design specification. (Verify fixturing and clamping if applicable) Also if there are any critical environmental issues that are interdependent with the measurement. Phase 1 could use a statistically designed experiment to evaluate the effect of the operating environment on the measurement system’s parameters (e.g., bias, linearity, repeatability, and reproducibility). Phase 1 test results can indicate that the operating environment does not contribute significantly to the overall measurement system variation. Additionally, the variation attributable to the bias and linearity of the measurement device should be small compared with the repeatability and reproducibility components. The knowledge gained during Phase 1 testing should be used as input to the development of the measurement system maintenance program as well as the type of testing which should be used during Phase 2. Environmental issues may drive a change in location or a controlled environment for the measurement device.

Does the measurement process satisfy the requirements over time?

For example, if there is a significant impact of repeatability and reproducibility on the total measurement system variation, a simple twofactor statistical experiment could be performed periodically as a Phase 2 test. Phase 2 testing provides ongoing monitoring of the key sources of variation for continued confidence in the measurement system (and the data being generated) and/or a signal that the measurement system has degraded over time.

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Chapter II – Section A Background

70

Chapter II – Section B Selecting/Developing Test Procedures

Section B Selecting/Developing Test Procedures “Any technique can be useful if its limitations are understood and observed.” 25 P

Many appropriate procedures are available for assessing measurement systems. The choice of which procedure to use depends on many factors, most of which need to be determined on a case-by-case basis for each measurement system to be assessed. In some cases, preliminary testing may be required to determine if a procedure is appropriate for a particular measurement system or not. Such preliminary testing ought to be an integral part of the Phase 1 testing discussed in the previous section. General issues to consider when selecting or developing an assessment procedure include: x

x

x x x

25

26

Should standards, such as those traceable to NIST, be used in the testing and, if so, what level of standard is appropriate? Standards are frequently essential for assessing the accuracy of a measurement system. If standards are not used, the variability of the measurement system can still be assessed, but it may not be possible to assess its accuracy with reasonable credibility. Lack of such credibility may be an issue, for instance, if attempting to resolve an apparent difference between a producer’s measurement system and a customer’s measurement system. For the ongoing testing in Phase 2, the use of blind measurements may be considered. Blind measurements are measurements obtained in the actual measurement environment by an operator who does not know that an assessment of the measurement system is being conducted. Properly administered, tests based on blind measurements are usually not contaminated by the well-known Hawthorne effect. 26 P

The cost of testing. The time required for the testing. Any term for which there is no commonly accepted definition should be operationally defined. Examples of such terms include accuracy, precision, repeatability, reproducibility, etc.

W. Edwards Deming, The Logic of Evaluation, The Handbook of Evaluation Research, Vol. 1, Elmer L. Struening and Marcia Guttentag, Editors The “Hawthorne Effect” refers to the outcomes of a series of industrial experiments performed at the Hawthorne Works of Western Electric between November 1924 and August 1932. In the experiments, the researchers systematically modified working conditions of five assemblers and monitored the results. As the conditions improved, production rose. However, when working conditions were degraded, production continued to improve. This was thought to be the results of the workers having developed a more positive attitude toward the work solely as a result of them being part of the study, rather than as a result of the changed working conditions. See A History of the Hawthorne Experiments, by Richard Gillespie, Cambridge University Press, New York, 1991.

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Chapter II – Section B Selecting/Developing Test Procedures

x

x

Will the measurements made by the measurement system be compared with measurements made by another system? If so, one should consider using test procedures that rely on the use of standards such as those discussed in Phase 1 above. If standards are not used, it may still be possible to determine whether or not the two measurement systems are working well together. However, if the systems are not working well together, then it may not be possible, without the use of standards, to determine which system needs improvement. How often should Phase 2 testing be performed? This decision may be based on the statistical properties of the individual measurement system and the consequence to the facility, and the facility’s customers of a manufacturing process that, in effect, is not monitored due to a measurement system not performing properly.

In addition to these general issues, other issues that are specific to the particular measurement system being tested may also be important. Finding the specific issues that are important to a particular measurement system is one of the two objectives of the Phase 1 testing.

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Chapter II – Section C Preparation for a Measurement System Study

Section C Preparation for a Measurement System Study As in any study or analysis, sufficient planning and preparation ought to be done prior to conducting a measurement system study. Typical preparation prior to conducting the study is as follows: 1) The approach to be used should be planned. For instance, determine by using engineering judgment, visual observations, or a gage study, if there is an appraiser influence in calibrating or using the instrument. There are some measurement systems where the effect of reproducibility can be considered negligible; for example, when a button is pushed and a number is printed out. 2) The number of appraisers, number of sample parts, and number of repeat readings should be determined in advance. Some factors to be considered in this selection are: (a) Criticality of dimension – critical dimensions require more parts and/or trials. The reason being the degree of confidence desired for the gage study estimations. (b) Part configuration – bulky or heavy parts may dictate fewer samples and more trials. (c) Customer requirements. 3) Since the purpose is to evaluate the total measurement system, the appraisers chosen should be selected from those who normally operate the instrument. 4) Selection of the sample parts is critical for proper analysis and depends entirely upon the design of the MSA study, purpose of the measurement system, and availability of part samples that represent the production process. For Product Control situations where the measurement result and decision criteria determine, “conformance or nonconformance to the feature specification” (i.e., 100% inspection or sampling), samples (or standards) must be selected, but need not cover the entire process range. The assessment of the measurement system is based on the feature tolerance (i.e., %GRR to TOLERANCE). For Process Control situations where the measurement result and decision criteria determine, “process stability, direction and compliance with the natural process variation” (i.e., SPC, process monitoring, capability, and process improvement), the availability of samples over the entire operating range becomes very important. An independent estimate of process variation (process capability study) is recommended when assessing the adequacy of the measurement system for process control (i.e., %GRR to process variation).

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Chapter II – Section C Preparation for a Measurement System Study

When an independent estimate of process variation is not available, OR to determine process direction and continued suitability of the measurement system for process control, the sample parts must be selected from the process and represent the entire production operating range. The variation in sample parts (PV) selected for MSA study is used to calculate the Total Variation (TV) of the study. The TV index (i.e., %GRR to TV) is an indicator of process direction and continued suitability of the measurement system for process control. If the sample parts DO NOT represent the production process, TV must be ignored in the assessment. Ignoring TV does not affect assessments using tolerance (product control) or an independent estimate of process variation (process control). Samples can be selected by taking one sample per day for several days. Again, this is necessary because the parts will be treated in the analysis as if they represent the range of production variation in the process. Since each part will be measured several times, each part must be numbered for identification. 5) The instrument should have a discrimination that allows at least one-tenth of the expected process variation of the characteristic to be read directly. For example, if the characteristic’s variation is 0.001, the equipment should be able to “read” a change of 0.0001. 6) Assure that the measuring method (i.e., appraiser and instrument) is measuring the dimension of the characteristic and is following the defined measurement procedure. The manner in which a study is conducted is very important. All analyses presented in this manual assume statistical independence 27 of the individual readings. To minimize the likelihood of misleading results, the following steps need to be taken: P

F

1) The measurements should be made in a random order 28 to ensure that any drift or changes that could occur will be spread randomly throughout the study. The appraisers should be unaware of which numbered part is being checked in order to avoid any possible knowledge bias. However, the person conducting the study should know which numbered part is being checked and record the data accordingly, that is Appraiser A, Part 1, first trial; Appraiser B, Part 4, second trial, etc. P

F

2) In reading the equipment, measurement values should be recorded to the practical limit of the instrument discrimination. Mechanical devices must be read and recorded to the smallest unit of scale discrimination. For electronic readouts, the measurement plan must establish a common policy for recording the right-most significant digit of display. Analog devices should 27 28

There is no correlation between readings. See Chapter III, Section B, “Randomization and Statistical Independence”

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Chapter II – Section C Preparation for a Measurement System Study

be recorded to one-half the smallest graduation or limit of sensitivity and resolution. For analog devices, if the smallest scale graduation is 0.0001”, then the measurement results should be recorded to 0.00005”. 3) The study should be managed and observed by a person who understands the importance of conducting a reliable study. When developing Phase 1 or Phase 2 test programs there are several factors that need to be considered: x

x x

What effect does the appraiser have on the measurement process? If possible, the appraisers who normally use the measurement device should be included in the study. Each appraiser should use the procedure – including all steps – they normally use to obtain readings. The effect of any differences between methods the appraisers use will be reflected in the Reproducibility of the measurement system.

Is appraiser calibration of the measurement equipment likely to be a significant cause of variation? If so, the appraisers should recalibrate the equipment before each group of readings. How many sample parts and repeated readings are required? The number of parts required will depend upon the significance of the characteristic being measured and upon the level of confidence required in the estimate of measurement system variation. Although the number of appraisers, trials and parts may be varied when using the recommended practices discussed in this manual, the number of appraisers, trials and parts should remain constant between Phase 1 and Phase 2 test programs or between sequential Phase 2 tests for common measurement systems. Maintaining commonality between test programs and sequential tests will improve comparisons between the various test results.

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Chapter II – Section C Preparation for a Measurement System Study

76

Chapter II – Section D Analysis of the Results

Section D Analysis of the Results The results should be evaluated to determine if the measurement device is acceptable for its intended application. A measurement system should be stable before any additional analysis is valid. Acceptability Criteria – Gage Assembly and Fixture Error

Assembly or Fixture Error

An improperly designed fixture or poorly assembled gage will increase measurement error. This is normally found when the measurements indicate or display process instability or out-of-control conditions. This may be due to excessive gage variation or poor repeatability and poor GRR values. In general, the first thing to do when an apparent measurement issue exists, is to review the assembly and setup instructions to make sure the gage was properly assembled, (NOTE: this will not be in the instructions) and, for example, the clamps/probes are positioned properly and have the right load. Also, for automated measurement, verify the program follows required or expected protocol. If problems are found in any of these areas, reset or repair the gage and fixtures, then rerun the measurement evaluation. Acceptability Criteria – Location Error

Location Error

Location error is normally defined by analyzing bias and linearity. In general, the bias or linearity error of a measurement system is unacceptable if it is significantly different from zero or exceeds the maximum permissible error established by the gage calibration procedure. In such cases, the measurement system should be recalibrated or an offset correction applied to minimize this error. Acceptability Criteria – Width Error

Width Error

The criteria as to whether a measurement system’s variability is satisfactory are dependent upon the percentage of the manufacturing production process variability or the part tolerance that is consumed by measurement system variation. The final acceptance criteria for specific measurement systems depend on the measurement system’s environment and purpose and should be agreed to by the customer. (See Chapter I Section B- “The Effects of Measurement System Variability”) When beginning to evaluate an organization’s measurement systems, it can be useful to set priorities on which measurement systems to initially focus. Since the final (total) variation is based on a combination of the process and measurement variation, ( V Total

2 2 V Process  V MSA ), when SPC is being applied for

process control or collecting process data, and the control chart indicates that the process is stable and the total variation is acceptable, the measurement system can be considered

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Chapter II – Section D Analysis of the Results

acceptable for this use and does not require separate reevaluation 29 . If an out-of-control condition or nonconformance is found in this situation, the first thing that should be done is to evaluate the measurement system. P

F

For measurement systems whose purpose is to analyze a process, a general guidelines for measurement system acceptability is as follows: GRR

Decision

Comments

Under 10 percent

Generally considered to be an acceptable measurement system.

Recommended, especially useful when trying to sort or classify parts or when tightened process control is required.

10 percent to 30 percent

May be acceptable for some applications

Decision should be based upon, for example, importance of application measurement, cost of measurement device, cost of rework or repair. Should be approved by the customer.

Over 30 percent

Considered to be unacceptable

Every effort should be made to improve the measurement system. This condition may be addressed by the use of an appropriate measurement strategy; for example, using the average result of several readings of the same part characteristic in order to reduce final measurement variation.

Table II-D 1: GRR Criteria Additional Width Error Metric Another statistic of the measurement system variability is the number of distinct categories (ndc) 30 . This statistic indicates the number of categories into which the measurement process can be divided. This value should be greater than or equal to 5. P

F

Caution: The use of the GRR guidelines as threshold criteria alone is NOT an acceptable practice for determining the acceptability of a measurement system.

29

30

If the total process is in statistical control for both the mean and variation charts and the total variation is acceptable then it can be assumed either (1) both the actual process and measurement variability are acceptable or (2) the measurement variation is not acceptable with respect to the process variation (which is extremely small) but both are in statistical control. In either case the process is producing acceptable product. In case (2) the existence of a nonconformance or out of control condition could be a false alarm (i.e., the product is acceptable but the evaluation says it is not) which would cause an evaluation of both the measurement system and process. See Chapter I, Section E, “Measurement Issues”.

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Chapter II – Section D Analysis of the Results

Applying the guidelines as the thresholds assumes that the calculated statistics are deterministic estimates of the measurement system’s variability (which they are not). Specifying the guidelines as the threshold criteria can drive the wrong behavior. For example, the supplier may be creative in achieving a low GRR by eliminating real life sources of variation (e.g., part to gage interaction) or manipulating the measurement study (e.g., producing parts outside the expected process variation).

Comments on the Application and Gage Acceptability When looking at GRR and measurement variation it is important to look at each application individually, to see what is required and how the measurement is going to be used. For example: the required precision of temperature measurement may be different for dissimilar applications. A room thermostat can regulate the temperature for human comfort and is economically priced, but may have a GRR upwards to 30%. It is acceptable for this application. But in a laboratory, where small variations in temperature can impact test results, a more sophisticated temperature measurement and control is required. This thermostat will be more expensive and is required to have less variability (i.e., to have a lower GRR). The final acceptance of a measurement system should not come down to a single set of indices. The long-term performance of the measurement system should also be reviewed, for example, using graphical analysis over time.

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Chapter II – Section D Analysis of the Results

80

Chapter III Recommended Practices for Replicable Measurement Systems

CHAPTER III Recommended Practices for Replicable Measurement Systems

81

Chapter III – Section A Example Test Procedures

82

Chapter III – Section A Example Test Procedures

Section A Example Test Procedures Examples of specific test procedures are presented in this chapter. The procedures are simple to use and can be readily applied in a production environment. As discussed previously, the test procedure which should be used to understand a measurement system and to quantify its variability depends on the sources of variation which may affect the measurement system. In many situations the major sources of variation are due to the instrument (gage/equipment), person (appraiser), and method (measurement procedure). The test procedures in this chapter are sufficient for this type of measurement system analysis. The procedures are appropriate to use when:

9 Only two factors or conditions of measurement (i.e., appraisers and parts) plus measurement system repeatability are being studied 9 The effect of the variability within each part is negligible 9 There is no statistical interaction between appraisers and parts 9 The parts do not change functionally or dimensionally during the study, i.e., are replicable

A statistical design of experiment can be conducted and/or subject matter knowledge used to determine if these procedures are appropriate for any specific measurement system.

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Chapter III – Section A Example Test Procedures

84

Chapter III – Section B Variable Measurement System Study – Guidelines

Section B Variable Measurement System Study Guidelines This section contains implementation guidelines for the measurement system techniques described in Chapter I, Section E. A thorough review of Chapter I, Section E is recommended to ensure proper application of these guidelines.

Guidelines for Determining Stability Conducting the Study 1) Obtain a sample and establish its reference value(s) relative to a traceable standard. If one is not available, select a production part 31 that falls in the mid-range of the production measurements and designate it as the master sample for stability analysis. The known reference value is not required for tracking measurement system stability. P

Time

Reference Value

F

It may be desirable to have master samples for the low end, the high end, and the mid-range of the expected measurements. Separate measurements and control charts are recommended for each. 2) On a periodic basis (daily, weekly), measure the master sample three to five times. The sample size and frequency should be based on knowledge of the measurement system. Factors could include how often recalibration or repair has been required, how frequently the measurement system is used, and how stressful the operating conditions are. The readings need to be taken at differing times to represent when the measurement system is actually being used. This will account for warm-up, ambient or other factors that may change during the day. 3) Plot the data on an X & R or X & s control chart in time order.

Analysis of Results – Graphical 4) Establish control limits and evaluate for out-of-control or unstable conditions using standard control chart analysis.

31

Caution should be taken where a production master could experience excessive wear due to use, material, and handling. This may require modifying the production part, such as plating, to extend the life of the master.

85

Chapter III – Section B Variable Measurement System Study – Guidelines

Analysis of Results – Numerical Other than normal control chart analyses, there is no specific numerical analysis or index for stability. 32 P

F

If the measurement process is stable, the data can be used to determine the bias of the measurement system. Also, the standard deviation of the measurements can be used as an approximation for the measurement system’s repeatability. This can be compared with that of the process to determine if the measurement system repeatability is suitable for the application. Design of Experiments or other analytical problem solving techniques may be required to determine the prime contributors to the lack of measurement system stability.

Example – Stability To determine if the stability of a new measurement instrument was acceptable, the process team selected a part near the middle of the range of the production process. This part was sent to the measurement lab to determine the reference value which is 6.01. The team measured this part 5 times once a shift for four weeks (20 subgroups). After all the data were collected, X & R charts were developed (see Figure III-B 1).

Xbar/R Chart for Stability Sample Mean

6.3

UCL=6.297

6.2 6.1 6.021

6.0 5.9 5.8

LCL=5.746

5.7

Sample Range

Subgroup

0

10

20

1.0

UCL=1.010

0.5

0.4779

0.0

LCL=0

Figure III-B 1: Control Chart Analysis for Stability Analysis of the control charts indicates that the measurement process is stable since there are no obvious special cause effects visible.

32

See SPC Reference Manual.

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Chapter III – Section B Variable Measurement System Study – Guidelines

Guidelines for Determining Bias 33 – Independent Sample Method P

F

Conducting the Study The independent sample method for determining whether the bias is acceptable uses the Test of Hypothesis:

H 0 bias

0

H1 bias z 0

The calculated average bias is evaluated to determine if the bias could be due to random (sampling) variation. In general, the bias or linearity error of a measurement system is acceptable if it is not statistically significantly different from zero when compared to the repeatability. Consequently, the repeatability must be acceptable when compared to the process variation in order for this analysis to be useful.

1) Obtain a sample and establish its reference value relative to a traceable standard. If one is not available, select a production part that falls in the mid-range of the production measurements and designate it as the master sample for bias analysis. Measure the part n t 10 times in the gage or tool room, and compute the average of the n readings. Use this average as the “reference value.” It may be desirable to have master samples for the low end of the expected measurements, the high end, and the mid-range. If this is done, analyze the data using a linearity study.

2) Have a single appraiser measure the sample n t 10 times in the normal manner.

Analysis of Results – Graphical 3) Determine the bias of each reading:

biasi

xi  reference value

4) Plot the bias data as a histogram relative to the reference value. Review the histogram, using subject matter knowledge, to determine if any special causes or anomalies are present. If not, continue with the analysis. Special caution ought to be exercised for any interpretation or analysis when n < 30.

33

See Chapter I, Section E, for an operational definition and discussion of potential causes.

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Chapter III – Section B Variable Measurement System Study – Guidelines

Analysis of Results – Numerical 5) Compute the average bias of the n readings.

¦ biasi n

i

avg bias

1

n

6) Compute the repeatability standard deviation (see also Gage Study, Range Method, below):

¦ ( X i  X )2 n

V repeatability

Vr

i 1

n 1

If a GRR study is available (and valid), the repeatability standard deviation calculation should be based on the study results.

7) Determine if the repeatability is acceptable by calculating the %EV

= 100 [EV/TV] = 100 [ V repeatability /TV]

Where the total variation (TV) is based on the expected process variation (preferred) or the specification range divided by 6 (see also GRR study below). If the %EV is large (see Chapter II, section D), then the measurement system variation may be unacceptable. Since the bias analysis assumes that the repeatability is acceptable, continuing the analysis with a measurement system with a large %EV will lead to misleading and confusing results. TF Note: What specifically are we supposed to look at in Section D that links to EV?

8) Determine the t statistic for the bias: 34 F

Vb

Vr

t statistic

n

tbias

Vb

average bias

9) Bias is acceptable (statistically zero) at the D level if x

34

The uncertainty for bias is given by

the p-value associated with tbias is less than D; or

Vb . 88

Chapter III – Section B Variable Measurement System Study – Guidelines

x









zero falls within the 1-D confidence bounds based on the bias value:

Bias  ª ı b tQ , 1D º d zero d Bias  ª ı b tQ , 1D º «¬ «¬ 2 » 2 » ¼ ¼

where Q = n – 1 and

tQ ,1D is found using the standard t tables. 2

The D level which is used depends on the level of sensitivity which is needed to evaluate/control the process and is associated with the loss function (sensitivity curve) of the product/process. Customer agreement should be obtained if an D level other than the default value of .05 (95% confidence) is used.

Example – Bias A manufacturing engineer was evaluating a new measurement system for monitoring a process. An analysis of the measurement equipment indicated that there should be no linearity concerns, so the engineer had only the bias of the measurement system evaluated. A single part was chosen within the operating range of the measurement system based upon documented process variation. The part was measured by layout inspection to determine its reference value. The part was then measured fifteen times by the lead operator.

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Chapter III – Section B Variable Measurement System Study – Guidelines

Reference Value = 6.00

Bias

5.8 5.7 5.9 5.9 6.0 6.1 6.0 6.1 6.4 6.3 6.0 6.1 6.2 5.6 6.0

-0.2 -0.3 -0.1 -0.1 0.0 0.1 0.0 0.1 0.4 0.3 0.0 0.1 0.2 -0.4 0.0

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

T R I A L S

Table III-B 1: Bias Study Data Using a spreadsheet and statistical software, the supervisor generated the histogram and numerical analysis (see Figure III-B 2 & Table III-B 2).

4

Frequency

3

2

1

0 5.6

5.7

5.8

5.9

6.0

6.1

Measured value

90

6.2

6.3

6.4

Chapter III – Section B Variable Measurement System Study – Guidelines

Histogram of Study-bias (with Ho and 95% t-confidence interval for the mean) 4

Frequency

3

2

1

_ X

0

Ho

-0.4

-0.2

0.0 Study-bias

0.2

0.4

Figure III-B 2: Bias Study – Histogram of Bias Study The histogram did not show any anomalies or outliers requiring additional analysis and review. The repeatability of 0.2120 was compared to an expected process variation (standard deviation) of 2.5. Since the %EV = 100(.2120/2.5) = 8.5%, the repeatability is acceptable and the bias analysis can continue. Since zero falls within the confidence interval of the bias (– 0.1107, 0.1241), the engineer can assume that the measurement bias is acceptable assuming that the actual use will not introduce additional sources of variation.

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Chapter III – Section B Variable Measurement System Study – Guidelines

Measured Value

n

Average

15

6.0067

Standard Deviation, V r 0.2120

Reference Value = 6.00,

t statistic Measured Value

0.12

df

14

Significant t value (2-tailed) 2.14479

Standard Error of Mean, V b 0.0547

D =.05 95% Confidence Interval of the Bias

Average Bias .0067

Lower

Upper

-0.1107

0.1241

Table III-B 2: Bias Study – Analysis of Bias Study 35 P

Guidelines for Determining Bias – Control Chart Method Conducting the Study If an X & R chart is used to measure stability, the data can also be used to evaluate bias. The control chart analysis should indicate that the measurement system is stable before the bias is evaluated. 1) Obtain a sample and establish its reference value relative to a traceable standard. If one is not available, select a production part that falls in the mid-range of the production measurements and designate it as the master sample for bias analysis. Measure the part n t 10 times in the gage or tool room, and compute the average of the n readings. Use this average as the “reference value.” 2) Conduct the stability study with g (subgroups) • 20 subgroups of size m.

35

Even though data is given with one digit after the decimal point, the results are shown as provided by a typical statistical program using double precision; i.e., with multiple decimal digits.

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Chapter III – Section B Variable Measurement System Study – Guidelines

Analysis of Results – Graphical 3) If the control chart indicates that the process is stable and m = 1, use the analysis described for the independent sample method (see above). 4) If m • 2, plot the data as a histogram relative to the reference value. Review the histogram, using subject matter knowledge, to determine if any special causes or anomalies are present. If not, continue with the analysis.

Analysis of Results – Numerical 5) Obtain the X from the control chart

6) Compute the bias by subtracting the reference value from X . bias = X – reference value 7) Compute the repeatability standard deviation using the Average Range

V repeatability

R d 2*

where d 2* is based on the subgroup size (m) and the number of subgroups in the chart (g). (see Appendix C) 8) Determine if the repeatability is acceptable by calculating the %EV

= 100 [EV/TV] = 100 [ V repeatability /TV]

Where the total variation (TV) is based on the expected process variation (preferred) or the specification range divided by 6 (see also GRR study below). If the %EV is large (see Chapter II, section D), then the measurement system variation may be unacceptable. Since the bias analysis assumes that the repeatability is acceptable, continuing the analysis with a measurement system with a large %EV will lead to misleading and confusing results; i.e., the analysis can indicate that the bias is statistically zero while the absolute magnitude of the bias exceeds acceptable equipment values.

93

Chapter III – Section B Variable Measurement System Study – Guidelines

9) Determine the t statistic for the bias: 36

Vb

Vr

P

gm

t statistic

Vb

bias

tbias

10) Bias is acceptable (statistically zero) at the D level if zero falls within the 1- D confidence bounds around the bias value:









Bias  ª ı b tQ , 1D º d zero d Bias  ª ı b tQ , 1D º «¬ «¬ 2 » 2 » ¼ ¼

where Q is found in Appendix C

and tQ ,1D is found using the standard t tables. 2

The D level which is used depends on the level of sensitivity which is needed to evaluate/control the process and is associated with the loss function (sensitivity curve) of the product/process. Customer agreement should be obtained if an D level other than the default value of .05 (95% confidence) is used.

Example – Bias Referencing Figure III-B 1, the stability study was performed on a part which had a reference value of 6.01. The overall average of all the samples (20 subgroups of size 5 for n=100 samples) was 6.021. The calculated bias is therefore 0.011. Using a spreadsheet and statistical software, the supervisor generated the numerical analysis (Table III-B 3). Since zero falls within the confidence interval of the bias (-0.0299, 0.0519), the process team can assume that the measurement bias is acceptable assuming that the actual use will not introduce additional sources of variation.

36

The uncertainty for bias is given by

Vb . 94

Chapter III – Section B Variable Measurement System Study – Guidelines

Measured Value

n

Mean, X

100

6.021

Standard Deviation, V r .2048

Standard Error of Mean, V b .02048

Reference Value = 6.01, D =.05, m = 5, g = 20, d 2 = 2.334, d 2 = 2.326 *

P

t statistic Measured Value

.5371

df

72.7

Significant t value (2-tailed)

Bias

1.993

.011

95% Confidence Interval of the Bias Lower

Upper

-.0299

.0519

Table III-B 3: Bias Study – Analysis of Stability Study for Bias

Analysis of Bias Studies If the bias is statistically non-zero, look for these possible causes: x

x

x

Error in master or reference value. Check mastering procedure. Worn instrument. This can show up in the stability analysis and will suggest the maintenance or refurbishment schedule.

x

Instrument made to wrong dimension.

x

Instrument not calibrated properly. Review calibration procedure.

x

x

Instrument measuring the wrong characteristic.

Instrument used improperly by appraiser. Review measurement instructions. Instrument correction algorithm incorrect.

If the measurement system has non-zero bias, where possible it should be recalibrated to achieve zero bias through the modification of the hardware, software or both. If the bias cannot be adjusted to zero, it still can be used through a change in procedure (e.g., adjusting each reading by the bias). Since this has a high risk of appraiser error, it should be used only with the concurrence of the customer.

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Chapter III – Section B Variable Measurement System Study – Guidelines

Guidelines for Determining Linearity 37 P

Conducting the Study Linearity can be evaluated using the following guidelines: Value 1

Value N

1) Select g t 5 parts whose measurements, due to process variation, cover the operating range of the gage. 2) Have each part measured by layout inspection to determine its reference value and to confirm that the operating range of the subject gage is encompassed.

3) Have each part measured m t 10 times on the subject gage by one of the operators who normally use the gage. 9 Select the parts at random to minimize appraiser “recall” bias in the measurements.

Analysis of Results – Graphical 4) Calculate the part bias for each measurement and the bias average for each part.

biasi , j

xi , j   reference value i

¦ biasi, j m

biasi

j

1

m

5) Plot the individual biases and the bias averages with respect to the reference values on a linear graph. (see Figure III-B 3.) 6) Calculate and plot the best fit line and the confidence band of the line using the following equations. For the best fit line, use: yi

a xi  b

where

xi = reference value yi = bias average and

37

See Chapter I, Section E, for an operational definition and discussion of potential causes.

96

Chapter III – Section B Variable Measurement System Study – Guidelines

¦ xy  ¨ gm ¦ x¦ y ¸ § 1 ©

2 1 ¦ x 2  gm  ¦ x

a

y  ax

b

· ¹

slope

intercept

For a given x 0 , the D level confidence bands 38 are:

¦ yi2  b¦ yi  a¦ xi yi P

where s

ª « lower: b  a x0  «t gm  2,1D « ¬

ª « upper: b  a x0  «t gm  2,1D « ¬

gm  2

§ ¨ 1  2 ¨ gm © § ¨ 1  2 ¨ gm ©

F

 x0  x

¦

· ¸ 2  xi  x ¸¹

¦

· ¸ 2  xi  x ¸¹

1

2

 x0  x

2

1

2

2

º » s» » ¼

º » s» » ¼

7) The standard deviation of the variability of repeatability.

V repeatability

s

Determine if the repeatability is acceptable by calculating the %EV

= 100 [EV/TV] = 100 [ V repeatability /TV]

Where the total variation (TV) is based on the expected process variation (preferred) or the specification range divided by 6 (see also GRR study below). If the %EV is large (see Chapter II, section D), then the measurement system variation may be unacceptable. Since the bias analysis assumes that the repeatability is acceptable, continuing the analysis with a measurement system with a large %EV will lead to misleading and confusing results.

8) Plot the “bias = 0” line and review the graph for indications of special causes and the acceptability of the linearity. (see example Figure III-B 3.)

38

See the note on selecting the D level in the “Guidelines for Determining Bias” area in Chapter III, Section B.

97

Chapter III – Section B Variable Measurement System Study – Guidelines

For the measurement system linearity to be acceptable, the “bias = 0” line must lie entirely within the confidence bands of the fitted line.

Analysis of Results – Numerical 9) If the graphical analysis indicates that the measurement system linearity is acceptable then the following hypothesis should be true: H0: a = 0

slope = 0

do not reject if

ª « « « ¬

t

a

¦xj

s

x



2

º » » » ¼

d t gm 2, 1D

2

If the above hypothesis is true then the measurement system has the same bias for all reference values. For the linearity to be acceptable this bias must be zero. Ho: b = 0

intercept (bias) = 0

do not reject if

ª 1 «  « gm ¬

t

b

¦  xi  x x

2

2

º » s » ¼

d t gm 2, 1D

2

Example – Linearity A plant supervisor was introducing a new measurement system to the process. As part of the PPAP 39 the linearity of the measurement system needed to be evaluated. Five parts were chosen throughout the operating range of the measurement system based upon documented process variation. Each part was measured by layout inspection to determine its reference value. Each part was then measured twelve times by the lead operator. The parts were selected at random during the study. P

39

Production Parts Approval Process manual, 4th Edition, 2006

98

F

Chapter III – Section B Variable Measurement System Study – Guidelines

T R I A L S

Part Reference Value 1 2 3 4 5 6 7 8 9 10 11 12

1

2

3

4

5

2.00 2.70 2.50 2.40 2.50 2.70 2.30 2.50 2.50 2.40 2.40 2.60 2.40

4.00 5.10 3.90 4.20 5.00 3.80 3.90 3.90 3.90 3.90 4.00 4.10 3.80

6.00 5.80 5.70 5.90 5.90 6.00 6.10 6.00 6.10 6.40 6.30 6.00 6.10

8.00 7.60 7.70 7.80 7.70 7.80 7.80 7.80 7.70 7.80 7.50 7.60 7.70

10.00 9.10 9.30 9.50 9.30 9.40 9.50 9.50 9.50 9.60 9.20 9.30 9.40

Table III-B 4: Linearity Study Data Using a spreadsheet and statistical software, the supervisor generated the linearity plot (Figure III-B 3).

B I A S

Part Reference Value 1 2 3 4 5 6 7 8 9 10 11 12 BIAS Avg.

1

2

3

4

5

2.00 0.7 0.5 0.4 0.5 0.7 0.3 0.5 0.5 0.4 0.4 0.6 0.4 0.491667

4.00 1.1 -0.1 0.2 1.0 -0.2 -0.1 -0.1 -0.1 -0.1 0.0 0.1 -0.2 0.125

6.00 -0.2 -0.3 -0.1 -0.1 0.0 0.1 0.0 0.1 0.4 0.3 0.0 0.1 0.025

8.00 -0.4 -0.3 -0.2 -0.3 -0.2 -0.2 -0.2 -0.3 -0.2 -0.5 -0.4 -0.3 -0.29167

10.00 -0.9 -0.7 -0.5 -0.7 -0.6 -0.5 -0.5 -0.5 -0.4 -0.8 -0.7 -0.6 -0.61667

Table III-B 5: Linearity Study – Intermediate Results

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Chapter III – Section B Variable Measurement System Study – Guidelines

Linearity Example Y = 0.736667 - 0.131667X R-Sq = 71.4 %

Bias

1

Bias = 0

0

Regression 95% CI Bias Average

-1 2

3

4

5

6

7

8

9

10

Reference Values Figure III-B 3: Linearity Study – Graphical Analysis The graphical analysis indicates that special causes may be influencing the measurements system. The data for reference value 4 appear to be bimodal. Even if the data for reference value 4 were not considered, the graphical analysis clearly shows that this measurement system has a linearity problem. The R2 value indicates that a linear model may not be an appropriate model for these data. 40 Even if the linear model is accepted, the “bias = 0” line intersects the confidence bounds rather than being contained by them. P

F

At this point, the supervisor ought to begin problem analysis and resolution on the measurement system, since the numerical analysis will not provide any additional insights. However, wanting to make sure no paperwork is left unmarked, the supervisor calculates the t-statistic for the slope and intercept:

ta

 12.043

tb

10.158

Taking the default D = .05 and going to the t-tables with (gm – 2) = 58 degrees of freedom and a proportion of .975, the supervisor comes up with the critical value of:

40

See standard statistical texts on analysis of the appropriateness of using a linear model to describe the relationship between two variables.

100

Chapter III – Section B Variable Measurement System Study – Guidelines

t58, .975

Since ta

2.00172

! t58, .975 , the result obtained from the graphical analysis is

reinforced by the numerical analysis – there is a linearity problem with this measurement system. In this case, it does not matter what relation tb has to t58, .975 since there is a linearity problem. Possible causes for linearity problems can be found in Chapter I, Section E, “Location Variation.” If the measurement system has a linearity problem, it needs to be recalibrated to achieve zero bias through the modification of the hardware, software or both. If the bias cannot be adjusted to zero bias throughout the measurement system range, it still can be used for product/process control but not analysis as long as the measurement system remains stable. Since this has a high risk of appraiser error, it should be used only with the concurrence of the customer.

Guidelines for Determining Repeatability and Reproducibility 41 P

The Variable Gage Study can be performed using a number of differing techniques. Three acceptable methods will be discussed in detail in this section. These are: x x

x

Range method Average and Range method (including the Control Chart method) ANOVA method

Except for the Range method, the study data design is very similar for each of these methods. The ANOVA method is preferred because it measures the operator to part interaction gauge error, whereas the Range and the Average and Range methods does not include this variation. As presented, all methods ignore within-part variation (such as roundness, diametric taper, flatness, etc., as discussed in Chapter IV, Section D) in their analyses. The ANOVA approach can identify appraiser-part interaction but it can also evaluate other sources of variation which is the reason why it was included. Historically, the assumption is made that the interaction is zero, in which case the results of both approaches are equivalent. With that said, the ANOVA approach is preferred because of its flexibility if the user has access to a appropriate computer program. If not, the X bar and R approach is appropriate and can be done manually or via a computer program.

41

See Chapter I, Section E, for an operational definition and discussion of potential causes.

101

Chapter III – Section B Variable Measurement System Study – Guidelines

However, the total measurement system includes not only the gage itself and its related bias, repeatability, etc., but also could include the variation of the parts being checked. The determination of how to handle within-part variation needs to be based on a rational understanding of the intended use of the part and the purpose of the measurement. Finally, all of the techniques in this section are subject to the prerequisite of statistical stability. Although reproducibility is usually interpreted as appraiser variation, there are situations when this variation is due to other sources of variation. For example, with some in-process measurement systems there are no human appraisers. If all the parts are handled, fixtured and measured by the same equipment, then reproducibility is zero; i.e., only a repeatability study is needed. If, however, multiple fixtures are used, then the reproducibility is the between-fixture variation.

Range Method The Range method is a modified variable gage study which will provide a quick approximation of measurement variability. This method will provide only the overall picture of the measurement system. It does not decompose the variability into repeatability and reproducibility. It is typically used as a quick check to verify that the GRR has not changed. This approach has the potential to detect an unacceptable measurement system 42 80% of the time with a sample size of 5 and 90% of the time with a sample size of 10. P

F

The Range method typically uses two appraisers and five parts for the study. In this study, both appraisers measure each part once. The range for each part is the absolute difference between the measurement obtained by appraiser A and the measurement obtained by appraiser B. The sum of the ranges is found and the average range ( R ) is calculated. The total measurement 1 variability is found by multiplying the average range by * where d 2* is d2 found in Appendix C, with m = 2 and g = number of parts.

42

Parts

Appraiser A

Appraiser B

Range (A, B)

1

0.85

0.80

0.05

2

0.75

0.70

0.05

3

1.00

0.95

0.05

4

0.45

0.55

0.10

5

0.50

0.60

0.10

i.e., %GRR > 30%

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Chapter III – Section B Variable Measurement System Study – Guidelines

AverageRange ( R ) GRR

§R· ¨ *¸ © d2 ¹

¦R

0.35 5 § 0.07 · ¨ ¸ © 1.19 ¹

i

5 § R · ¨ ¸ © 1.19 ¹

0.07 0.0588

(Process Standard Deviation = 0.0777 from previous study)

%GRR

§ · GRR 100 * ¨ ¸ © Process Standard Deviation ¹

75.7%

Table III-B 6: Gage Study (Range Method)

To determine what percentage of the process standard deviation the measurement variation consumes, convert the GRR to a percentage by multiplying by 100 and dividing by the process standard deviation. In the example (see Table III-B 6), the process standard deviation for this characteristic is 0.0777, therefore,

%GRR

§ · GRR 100 * ¨ ¸ © Process Standard Deviation ¹

75.7%

Now that the %GRR for the measurement system is determined, an interpretation of the results should be made. In Table III-B 6, the %GRR is determined to be 75.7% and the conclusion is that the measurement system is in need of improvement.

Average and Range Method The Average and Range method ( X & R) is an approach which will provide an estimate of both repeatability and reproducibility for a measurement system. Unlike the Range method, this approach will allow the measurement system’s variation to be decomposed into two separate components, repeatability and reproducibility. 43 However, variation due to the interaction between the appraiser and the part/gage is not accounted for in the analysis. P

43

F

The ANOVA method can be used to determine the interaction between the gage and appraisers, if such exists.

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Chapter III – Section B Variable Measurement System Study – Guidelines

Conducting the Study Although the number of appraisers, trials and parts may be varied, the subsequent discussion represents the optimum conditions for conducting the study. Refer to the GRR data sheet in III-B 6a. The detailed procedure is as follows: 1) Obtain a sample of n > 10 parts 44 that represent the actual or expected range of process variation. P

F

2) Refer to the appraisers as A, B, C, etc. and number the parts 1 through n so that the numbers are not visible to the appraisers. See Chapter II, Section C.

3) Calibrate the gage if this is part of the normal measurement system procedures. Let appraiser A measure n parts in a random order 45 and enter the results in row 1. P

F

4) Let appraisers B and C measure the same n parts without seeing each other’s readings; then enter the results in rows 6 and 11, respectively. 5) Repeat the cycle using a different random order of measurement. Enter data in rows 2, 7 and 12. Record the data in the appropriate column. For example if the first piece measured is part 7 then record the result in the column labeled part 7. If three trials are needed, repeat the cycle and enter data in rows 3, 8 and 13. 6) Steps 4 and 5 may be changed to the following when large part size or simultaneous unavailability of parts makes it necessary: 9 Let appraiser A measure the first part and record the reading in row 1. Let appraiser B measure the first part and record the reading in row 6. Let appraiser C measure the first part and record the reading in row 11. 9 Let appraiser A repeat reading on the first part and record the reading in row 2, appraiser B record the repeat reading in row 7, and appraiser C record the repeat reading in row 12. Repeat this cycle and enter the results in rows 3, 8, and 13, if three trials are to be used.

7) An alternative method may be used if the appraisers are on different shifts. Let appraiser A measure all 10 parts and enter the reading in row 1. Then have appraiser A repeat the reading in a different order and enter the results in rows 2 and 3. Do the same with appraisers B and C.

44

45

The total number of “ranges” generated ought to be > 15 for a minimal level of confidence in the results. Although the form was designed with a maximum of 10 parts, this approach is not limited by that number. As with any statistical technique, the larger the sample size, the less sampling variation and less resultant risk will be present. See Chapter III, Section B, “Randomization and Statistical Independence”

104

Chapter III – Section B Variable Measurement System Study – Guidelines

Gage Repeatability and Reproducibility Data Collection Sheet PART

Appraiser /Trial # 1

A

AVERAGE 1

2

3

4

5

6

7

8

9

10

1

0.29 -0.56

1.34

0.47 -0.80

0.02

0.59 -0.31

2.26

-1.36

2

2

0.41 -0.68

1.17

0.50 -0.92 -0.11

0.75 -0.20

1.99

-1.25

3

3

0.64 -0.58

1.27

0.64 -0.84 -0.21

0.66 -0.17

2.01

-1.31

4

Average

Xa =

5

Range

Ra =

6

B

1

0.08 -0.47

1.19

0.01 -0.56 -0.20

0.47 -0.63

1.80

-1.68

7

2

0.25 -1.22

0.94

1.03 -1.20

0.22

0.55

0.08

2.12

-1.62

8

3

0.07 -0.68

1.34

0.20 -1.28

0.06

0.83 -0.34

2.19

-1.50

9

Average

Xb =

10

Range

Rb =

11 C

1

0.04 -1.38

0.88

0.14 -1.46 -0.29

0.02 -0.46

1.77

-1.49

12

2

-0.11 -1.13

1.09

0.20 -1.07 -0.67

0.01 -0.56

1.45

-1.77

13

3

-0.15 -0.96

0.67

0.11 -1.45 -0.49

0.21 -0.49

1.87

-2.16

14

Average

Xc =

15

Range

Rc =

16

X = Rp =

Part Average

17 R 18 X

]  [ Rb

([ Ra

[Max X =

DIFF

19 * UCL

R

= [R =

]  [ Rc

]) /[# OF APPRAISERS

] - [Min X =

] u [D4

]

R=

]=

]=

*D 4 = 3.27 for 2 trials and 2.58 for 3 trials. UCL R represents the limit of individual R’s. Circle those that are beyond this limit. Identify the cause and correct. Repeat these readings using the same appraiser and unit as originally used or discard values and re-average and recompute R and the limiting value from the remaining observations.

Notes:_____________________________________________________________________________________________________________

Table III-B 6a: Gage Repeatability and Reproducibility Data Collection Sheet

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Chapter III – Section B Variable Measurement System Study – Guidelines

Analysis of Results – Graphical 46 P

The use of graphical tools is very important. The specific graphical tools used depend on the experimental design employed to collect the data. A systematic screening of the data for apparent special causes of variations by using graphical tools should precede any other statistical analysis. The following are some of the techniques which have proven to be useful. (See also the Analysis of Variance Method). The data from the measurement system analysis can be displayed graphically by control charts. The idea of using control charts to answer questions concerning the measurement system has been used by Western Electric (see Reference List: AT&T Statistical Quality Control Handbook).

Average Chart

The averages of the multiple readings by each appraiser on each part are plotted by appraiser with part number as an index. This can assist in determining consistency between appraisers. The grand average and control limits determined by using the average range are also plotted. The resulting Average Chart provides an indication of “usability” of the measurement system. The area within the control limits represents the measurement sensitivity (“noise”). Since the group of parts used in the study represents the process variation, approximately one half or more of the averages should fall outside the control limits. If the data show this pattern, then the measurement system should be adequate to detect part-to-part variation and the measurement system can provide useful information for analyzing and controlling the process. If less than half fall outside the control limits then either the measurement system lacks adequate effective resolution or the sample does not represent the expected process variation.

46

Detailed descriptions of these analyses are beyond the scope of this document. For more information, refer to the references and seek assistance from competent statistical resources

106

Chapter III – Section B Variable Measurement System Study – Guidelines

Figure III-B 4: Average Chart – “Stacked” 47 P

Review of the charts indicates that the measurement system appears to have sufficient discrimination for processes with variation described by the sample parts. No appraiser-to-appraiser differences are readily apparent.

Average

2 1 0 -1 -2

Appr A

Appr B

Appr C

Figure III-B 5: Average Chart – “Unstacked”

47

With the ANOVA approach, this is also referred to as appraiser-by-part interaction chart

107

Chapter III – Section B Variable Measurement System Study – Guidelines

Range Chart

The range control chart is used to determine whether the process is in control. The reason being that no matter how large the measurement error may be, the control limits will allow for that error. That is why the special causes need to be identified and removed before a measurement study can be relevant. The ranges of the multiple readings by each appraiser on each part are plotted on a standard range chart including the average range and control limit(s). From the analysis of the data that are being plotted, several useful interpretations can be made. If all ranges are in control, all appraisers are doing the same job. If one appraiser is out-of-control, the method used differs from the others. If all appraisers have some out of control ranges, the measurement system is sensitive to appraiser technique and needs improvement to obtain useful data. Neither chart should display patterns in the data relative to the appraisers or parts. The ranges are not ordered data. Normal control chart trend analysis must not be used even if the plotted points are connected by lines. Stability is determined by a point or points beyond the control limit; within-appraiser or within-part patterns. Analysis for stability ought to consider practical and statistical significance.

The range chart can assist in determining: x x

Statistical control with respect to repeatability Consistency of the measurement process between appraisers for each part

Figure III-B 6: Range Chart – “Stacked”

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Chapter III – Section B Variable Measurement System Study – Guidelines

Range

1.0

0.5

0.0

Appr A

Appr B

Appr C

Figure III-B 7: Range Chart – “Unstacked”

Review of the above charts indicates that there are differences between the variability of the appraisers.

The individual readings are plotted by part for all appraisers (see Figure III-B 8) to gain insight into:

Run Chart

x x

The effect of individual parts on variation consistency Indication of outlier readings (i.e., abnormal readings)

Value

2 1 0 -1 -2

part

1

2

3

4

5

6

7

8

9

10

Figure III-B 8: Run Chart by Part

Review of the above chart does not indicate any outliers or inconsistent parts.

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Chapter III – Section B Variable Measurement System Study – Guidelines

The individual readings are plotted by part-by-appraiser (see Figure III-B 9) to gain insight into:

Scatter Plot

x x x

Consistency between appraisers Indication of possible outliers Part-appraiser interactions

Review of the Figure III-B 9 does not indicate any significant outliers but does indicate that appraiser C may have lower readings than the other appraisers.

Value

2 1 0 -1 -2

Part

1

2

3

4

5

6

7

8

9

10

Value

2 1 0 -1 -2

Part

Appraiser

A

B

Figure III-B 9: Scatter Plot

110

C

Chapter III – Section B Variable Measurement System Study – Guidelines

In a Whiskers Chart, the high and low data values and the average by partby-appraiser are plotted (see Figure III-B 10). This provides insight into:

Whiskers Chart

x x x

Consistency between appraisers Indication of outliers Part-appraiser interactions

2

Value

1

0

-1

-2 Appr Part

1 2 3 1

1 2 3 2

1 2 3 3

1 2 3 4

1 2 3 5

1 2 3 6

1 2 3 7

1 2 3 8

1 2 3 9

1 2 3 10

Figure III-B 10: Whiskers Chart

Review of Figure III-B 10 does not indicate any significant outliers but indicates that appraiser B may have the most variability.

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Chapter III – Section B Variable Measurement System Study – Guidelines

The data from the measurement system analysis can be analyzed by running “Error Charts” (see Figure III-B 11) of the individual deviations from the accepted reference values. The individual deviation or error for each part is calculated as follows:

Error chart

Error = Observed Value – Reference Value or Error = Observed Value – Average Measurement of the Part This depends upon whether or not reference values of the data being measured are available.

error

0.5

0.0

-0.5 part

1

2

3

4

5

6

7

8

9

10

error

0.5

0.0

-0.5 part

Appraiser

A

B

C

Figure III-B 11: Error Charts

Review of the above charts indicates: x x

x

Appraiser A has an overall positive bias Appraiser B has the most variability but no apparent bias. Appraiser C has an overall negative bias

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Chapter III – Section B Variable Measurement System Study – Guidelines

The histogram plot (Figure III-B 12) is a graph that displays the frequency distribution of the gage error of appraisers who participated in the study. It also shows their combined frequency distribution.

Normalized Histogram

If the reference values are available: Error = Observed Value – Reference Value Otherwise: Normalized Value = Observed Value – Part Average

Frequency

The histogram plot provides a quick visual overview of how the error is distributed. Issues such as whether bias or lack of consistency exists in 7 the measurements taken by the 6 appraisers, can be identified even 5 before the data are analyzed. 4 3 2 1 0 0.00 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45

Appr A 5

Analysis of the histograms (Figure III-B 12) reinforces that of the error charts. They also indicate that only appraiser B has a symmetric form. This may indicate that appraisers A and C are introducing a systematic source of variation which is resulting in the biases.

Frequency

4 3 2 1 0 -0.4 -0.3 -0.2 -0.1 0.0

0.1

0.2 0.3

0.4 0.5

0.6

Appr B 7

Frequency

6 5 4 3 2 1 0 -0.7

-0.6

-0.5

-0.4

-0.3

Appr C

-0.2

-0.1

0.0

Error = 0 line

Figure III-B 12: Normalized Histogram 48 P

48

Note that the “0.0” of each of the histograms are aligned with respect to each other.

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Chapter III – Section B Variable Measurement System Study – Guidelines

The averages of the multiple readings by each appraiser on each part are plotted with the reference value or overall part averages as the index (see Figure III-B 13). This plot can assist in determining: x x

Linearity (if the reference value is used) Consistency in linearity between appraisers 3

2

2

1

1

Appr B

3

0 -1 -2

0 -1 -2

-3

-3 -3

-2

-1

0

1

2

3

-3

-2

-1

reference

0

reference

3 2

Appr C

Appr A

X-Y Plot of Averages by Size

1 0 -1 -2 -3 -3

-2

-1

0

1

2

3

reference

Figure III-B 13: X–Y Plot of Averages by Size

114

1

2

3

Chapter III – Section B Variable Measurement System Study – Guidelines

The averages of the multiple readings by each appraiser on each part are plotted against each other with the appraisers as indices. This plot compares the values obtained by one appraiser to those of another (see Figure III-B 14). If there were perfect agreement between appraisers, the plotted points would describe a straight line through the origin and 45° to the axis.

Comparison X-Y Plots

Appr A

1.25

Appr B

-1.25

1.25 Appr C -1.25 25 -1.

5 1. 2

25 -1.

5 1.2

Figure III-B 14: Comparison X–Y Plots

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Chapter III – Section B Variable Measurement System Study – Guidelines

Numerical Calculations

The Gage Repeatability and Reproducibility calculations are shown in Figures III-B 15 and III-B 16. Figure III-B 15 shows the data collection sheet on which all study results are recorded. Figure III-B 16 displays a report sheet on which all identifying information is to be recorded and all calculations made according to the prescribed formula.

Reproducible blank forms are available in the Sample Forms section. The procedure for doing the calculations after data have been collected is as follows:

(The following refers to Figure III-B 15) 1) Subtract the smallest reading from the largest reading in rows 1, 2 and 3; enter the result in row 5. Do the same for rows 6, 7, and 8; and 11, 12, and 13 and enter results in rows 10 and 15, respectively. 2) Entries in rows 5, 10 and 15 are ranges and therefore always positive values. 3) Total row 5 and divide the total by the number of parts sampled to obtain the average range for the first appraisers trials Ra . Do the same for rows 10 and 15 to obtain Rb and Rc . 4) Transfer the averages of rows 5, 10, and 15 ( Ra , Rb , Rc ) to row 17. Add them together and divide by the number of appraisers and enter results R (average of all ranges). 5) Enter R (average value) in rows 19 and multiply by D 4 49 to get the upper control limit. Note: D 4 is 3.27 if two trials are used. The value of the Upper Control Limit (UCL R ) of the individual ranges is entered in row 19. Note: The value of Lower Control Limit (LCL R ) for less than seven trials is equal to zero. P

F

6) Repeat any readings that produced a range greater than the calculated UCL R using the same appraiser and part as originally used, or discard those values and re-average and recompute R and the limiting value UCL R based upon the revised sample size. Correct the special cause that produced the out-of-control condition. If the data were plotted and analyzed using a control chart as discussed previously, this condition would have already been corrected and would not occur here. 7) Sum the rows (rows 1, 2, 3, 6, 7, 8, 11, 12, and 13). Divide the sum in each row by the number of parts sampled and enter these values in the right-most column labeled “Average”. 49

See Statistical Process Control (SPC) Reference Manual, 2005, or other statistical reference source for a table of factors.

116

Chapter III – Section B Variable Measurement System Study – Guidelines

8) Add the averages in rows 1, 2 and 3 and divide the total by the number of trials and enter the value in row 4 in the X a block. Repeat this for rows 6, 7 and 8; and 11, 12 and 13, and enter the results in the blocks for X b and X c in rows 9 and 14, respectively. 9) Enter the maximum and minimum averages of rows 4, 9 and 14 in the appropriate space in row 18 and determine the differences. Enter this difference in the space labeled X DIFF in row 18. 10) Sum the measurements for each trial, for each part, and divide the total by the number of measurements (number of trials times the number of appraisers). Enter the results in row 16 in the spaces provided for part average. 11) Subtract the smallest part average from the largest part average and enter the result in the space labeled R p in row 16. R p is the range of part averages. (The following refers to Figure III-B 16) 12) Transfer the calculated values of R , X DIFF and R p to the blanks provided on the report side of the form. 13) Perform the calculations under the column entitled “Measurement Unit Analysis” on the left side of the form. 14) Perform the calculations under the column entitled “% Total Variation” on the right side of the form. 15) Check the results to make sure no errors have been made.

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Chapter III – Section B Variable Measurement System Study – Guidelines

Gage Repeatability and Reproducibility Data Collection Sheet PART

Appraiser /Trial #

1

A

1

0.29

-0.56

1.34

0.47

-0.80

0.02

2

2

0.41

-0.68

1.17

0.50

3

3

0.64

-0.58

1.27

0.64

4

Average

0.447

-0.607

1.260

5

Range

0.35

0.12

0.17

0.17

1

0.08

-0.47

1.19

0.01

7

2

0.25

-1.22

0.94

8

3

0.07

-0.68

1.34

9

Average

0.133

-0.790

1.157

Range

0.18

0.75

0.40

1.02

1

0.04

-1.38

0.88

0.14

12

2

-0.11

-1.13

1.09

13

3

-0.15

-0.96

0.67

14

Average

-0.073

-1.157

0.880

15

Range

0.19

0.42

0.42

0.169

-0.851

1.099

1

6

B

10 11

C

16

AVERAGE 2

3

4

9

10

0.59 -0.31

2.26

-1.36

0.194

-0.92 -0.11

0.75 -0.20

1.99

-1.25

0.166

-0.84 -0.21

0.66 -0.17

2.01

-1.31

0.211

0.537 -0.853 -0.100

0.667 -0.227

2.087

-1.307

Xa =

0.1903

0.14

0.27

0.11

Ra =

0.184

-0.56 -0.20

0.47 -0.63

1.80

-1.68

0.001

1.03

-1.20

0.22

0.55

0.08

2.12

-1.62

0.115

0.20

-1.28

0.06

0.83 -0.34

2.19

-1.50

0.089

0.413 -1.013

0.027

0.617 -0.297

2.037

-1.600

Xb =

0.0683

0.71

0.39

0.18

Rb =

0.513

-1.46 -0.29

0.02 -0.46

1.77

-1.49

-0.223

0.20

-1.07 -0.67

0.01 -0.56

1.45

-1.77

-0.256

0.11

-1.45 -0.49

0.21 -0.49

1.87

-2.16

-0.284

0.150 -1.327 -0.483

0.080 -0.503

1.697

-1.807

Xc =

-0.2543

0.10

0.42

0.67

Rc =

0.328

0.454 -0.342

1.940

-1.571

X =

.0014

Rp =

3.511

R =

0.3417

0.09

5

0.12

0.72

0.39

6

0.23

0.42

0.38

0.367 -1.064 -0.186

7

0.16

0.36

0.20

8

Part Average 17 ([ R = 0.184] + [ R = 0.513] + [ R = 0.328]) / [ # OF APPRAISERS = 3] = 0.3417 a b c 18 [Max 19

*

X = 0.1903] – [Min X = -0.2543] = X DIFF = 0.4446

[ R = 0.3417] x [D 4 = 2.58] = UCL R = 0.8816

*D 4 = 3.27 for 2 trials and 2.58 for 3 trials. UCL R represents the limit of individual R’s. Circle those that are beyond this limit. Identify the cause and correct. Repeat these readings using the same appraiser and unit as originally used or discard values and re-average and recompute R and the limiting value from the remaining observations.

Notes:_____________________________________________________________________________________________________________

Figure III-B 15: Completed GR&R Data Collection Sheet

118

Chapter III – Section B Variable Measurement System Study – Guidelines

Gage Repeatability and Reproducibility Report Part No. & Name: Characteristics: Specifications:

Gage Name: Gage No: Gage Type:

Date: Performed by:

From data sheet: R = 0.3417

X DIFF = 0.4446

R p = 3.511 % Total Variation (TV)

Measurement Unit Analysis = R u K1

Repeatability – Equipment Variation (EV) EV

= 0.3417

%EV = 100 [EV/TV]

u 0.5908

Trials

K1

2

0.8862

3

0.5908

= 0.20188

 X DIFF u K 2 2 -

= 100 [0.20188/1.14610] = 17.62%

Reproducibility – Appraiser Variation (AV) AV

=

( EV

 0.4446 u 0.5231 2 -

=

= 0.22963 n = parts

2

%AV = 100 [AV/TV]

( nr ) ) ( 0.20188 (10 u 3) )

Appraisers

2

3

K2

0.7071

0.5231

r = trials

= 100 [0.22963/1.14610]

2

= 20.04%

Repeatability & Reproducibility (GRR) GRR

 AV

 0.201882  0.22963 2

=

EV

=

2

2

= 0.30575

Part Variation (PV) PV

Rp u K 3

=

= 1.10456 Total Variation (TV) TV

= =

 PV

 0.305752  1.10456 2 GRR

2

= 1.14610

2

%GRR = 100 [GRR/TV] = 100 [= 0.30575/1.14610]

Parts

K3

2

0.7071

3

0.5231

4

0.4467

5

0.4030

= 100 [1.10456/1.14610]

6

0.3742

= 96.38%

7

0.3534

8

0.3375

9

0.3249

10

0.3146

= 26.68%

% PV = 100 [PV/TV]

ndc



= 1.41 PV

GRR

= 1.41(1.10456/0.30575) = 5.094 ~ 5

For information on the theory and constants used in the form see MSA Reference Manual, Fourth edition.

Figure III-B 16: Gage Repeatability and Reproducibility Report

119



Chapter III – Section B Variable Measurement System Study – Guidelines

Analysis of Results — Numerical

The Gage Repeatability and Reproducibility Data Collection Sheet and Report forms, Figures III-B 15 and III-B 16, will provide a method for the numerical analysis of the study data 50 . The analysis will estimate the variation and percent of process variation for the total measurement system and its components repeatability, reproducibility, and part variation. This information needs to be compared to and complement the results of the graphical analysis. P

F

On the left side of the form (Figure III-B 16) under Measurement Unit Analysis, the standard deviation is calculated for each component of variation. The repeatability or equipment variation (EV or V E ) is determined by

multiplying the average range ( R ) by a constant (K 1 ). K 1 depends upon the number of trials used in the gage study and is equal to the inverse of d 2* which is obtained from Appendix C. d 2* is dependent on the number of trials (m) and the number of parts times the number of appraisers (g) (assumed to be greater than 15 for calculating the value of K 1 ) The reproducibility or appraiser variation (AV or V A ) is determined by

multiplying the maximum average appraiser difference ( X DIFF ) by a constant (K 2 ). K 2 depends upon the number of appraisers used in the gage study and is the inverse of d 2* which is obtained from Appendix C. d 2* is dependent on the number of appraisers (m) and g = 1, since there is only one range calculation. Since the appraiser variation is contaminated by the equipment variation, it must be adjusted by subtracting a fraction of the equipment variation. Therefore, the appraiser variation (AV) is calculated by

AV

X

DIFF

u K2



2

2 EV  

nr

where n = number of parts and r = number of trials. If a negative value is calculated under the square root sign, the appraiser variation (AV) defaults to zero. The measurement system variation for repeatability and reproducibility (GRR or V M ) is calculated by adding the square of the equipment variation and the square of the appraiser variation, and taking the square root as follows:

GRR

( EV ) 2  ( AV ) 2

There are generally four different approaches to determine the process variation which is used to analyze the acceptability of the measurement variation: 50

The numerical results in the example were developed as if they were computed manually; i.e., the results were carried and rounded to one additional decimal digit. Analysis by computer programs should maintain the intermediate values to the maximum precision of the computer/programming language. The results from a valid computer program may differ from the example results in the second or greater decimal place but the final analysis will remain the same.

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Chapter III – Section B Variable Measurement System Study – Guidelines

1) using process variation o o

process variation, taken from the parts in the GRR study itself use when the selected sample represents the expected process variation (preferred option)

2) surrogate process variation o use when sufficient samples to represent the process are not available but an existing process with similar process variation is available 3) Pp (or Ppk) target value o use when sufficient samples to represent the process are not available and an existing process with similar process variation is not available or the new process is expected to have less variability then an existing process 4) specification tolerance o When the measurement system is to be used to sort the process, and the process has a Pp